PHAT Phathom Pharmaceuticals Inc.

29.39
-0.11  0%
Previous Close 29.5
Open 29.15
52 Week Low 26
52 Week High 50.78
Market Cap $921,566,506
Shares 31,356,465
Float 20,563,110
Enterprise Value $770,530,881
Volume 119,580
Av. Daily Volume 127,378
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Upcoming Catalysts

Drug Stage Catalyst Date
Vonoprazan (PHALCON-NERD)
Non-erosive reflux disease (NERD)
Phase 2
Phase 2
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Vonoprazan PHALCON-EE
Erosive esophagitis / Gastroesophageal reflux disease (GERD)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
VONO-103 (Vonoprazan and Lansoprazole)
Erosive esophagitis / Gastroesophageal reflux disease (GERD)
Phase 1
Phase 1
Phase 1 trial demonstrated significantly greater acid inhibition as compared to lansoprazole and no serious adverse events were reported, September 27, 2021.
Vonoprazan PHALCON-HP
H. pylori
NDA Filing
NDA Filing
Phase 3 top-line data met primary endpoints - April 29, 2021. NDA filed September 8, 2021.

Latest News

  1. FLORHAM PARK, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that data for vonoprazan, an investigational potassium competitive acid blocker (P-CAB) in late clinical-stage development for the treatment of gastric acid-related disorders, will be presented at the ACG 2021 Annual Scientific Meeting in Las Vegas, Nevada, organized by the American College of Gastroenterology, October 22-27.  

    During the scientific congress, new data on vonoprazan will be shared in addition to novel insights into the burden of acid-related diseases, analysis of treatment…

    FLORHAM PARK, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that data for vonoprazan, an investigational potassium competitive acid blocker (P-CAB) in late clinical-stage development for the treatment of gastric acid-related disorders, will be presented at the ACG 2021 Annual Scientific Meeting in Las Vegas, Nevada, organized by the American College of Gastroenterology, October 22-27.  

    During the scientific congress, new data on vonoprazan will be shared in addition to novel insights into the burden of acid-related diseases, analysis of treatment patterns, and other newfound developments.

    "Phathom is committed to its mission as we seek to change the landscape for acid-related diseases," said Eckhard Leifke, M.D., Chief Medical Officer of Phathom. "We've conducted extensive research specifically on H. pylori and erosive esophagitis and look forward to sharing our data as well as updates on the disease burden for patients and providers with the GI community at the ACG 2021 Annual Scientific Meeting."

    In addition to four poster sessions and one oral presentation, Phathom will sponsor a product theater highlighting unmet needs in the treatment of H. pylori and will also have a presence on the exhibit floor at booth #929 throughout the conference and virtually via RethinkGIAcid.com.

    A high-level schedule of Phathom activities at the ACG 2021 Annual Scientific Meeting can be found below:

    Sunday, October 24, 2021

    • Phathom Poster Session

      3:30 PM – 7:00 PM
    • Phathom Poster Session

      3:30 PM – 7:00 PM

    Monday, October 25, 2021

    • Phathom Poster Session

      10:30 AM – 4:15 PM
    • Phathom Oral Session

      2:15 PM – 2:25 PM

    Tuesday, October 26, 2021

    • Medscape CME symposium sponsored by Phathom

      6:00 AM – 7:00 AM

      Presenters: Drs. William D. Chey, Colin Howden, Shailja Shah
    • Phathom Poster Session

      10:30 AM – 4:15 PM
    • Product Theater sponsored by Phathom

      10:35 AM – 11:30 AM

    Phathom will attend ACG 2021 having recently announced positive data from its pivotal Phase 3 PHALCON-EE trial which studied vonoprazan as a treatment option for erosive esophagitis (EE).

    Two New Drug Applications (NDAs) for vonoprazan-based regimens for the treatment of H. pylori infection were submitted to the U.S. FDA in September 2021. Based on the positive PHALCON-EE trial, Phathom also plans to submit an NDA to the FDA for the healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn by the end of the first half of 2022.

    About Vonoprazan

    Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has awarded qualified infectious disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom submitted NDAs in September 2021 to the FDA for vonoprazan-based regimens for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.

    About Phathom Pharmaceuticals, Inc.

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com and follow the Company on LinkedIn and Twitter.

    Forward Looking Statements

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected submission of an NDA for healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: reported top-line data is based on preliminary analysis of key efficacy and safety data is subject to more audit and verification procedures that could result in material changes in the final data; we may experience delays submitting the NDA including in the event that the FDA does not agree with the Company's interpretation of the data or feedback from the FDA that may be inconsistent with feedback received at prior meetings with the FDA; Phathom's ability to access additional capital under the term loan facility is subject to certain conditions including verification by the lender that the clinical milestone has been met; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom's QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    media@phathompharma.com

    Investor Contact:

    Joe Hand

    1-877-742-8466

    ir@phathompharma.com



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    • Vonoprazan met its primary non-inferiority endpoints in both healing and maintenance phases

    • Vonoprazan demonstrated superior healing rates in patients with moderate-to-severe disease at Week 2 versus lansoprazole (PREVACID®), a proton pump inhibitor (PPI)

    • Vonoprazan demonstrated superior maintenance of healing in all patients and patients with moderate-to-severe disease versus lansoprazole at Week 24

    • New Drug Application (NDA) submission planned for H1 2022 targeting the following indications: healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn

    • Phathom to host conference call today, October 18, 2021, at 8:30 am ET

    FLORHAM PARK, N.J., Oct. 18, 2021 (GLOBE…

    • Vonoprazan met its primary non-inferiority endpoints in both healing and maintenance phases



    • Vonoprazan demonstrated superior healing rates in patients with moderate-to-severe disease at Week 2 versus lansoprazole (PREVACID®), a proton pump inhibitor (PPI)



    • Vonoprazan demonstrated superior maintenance of healing in all patients and patients with moderate-to-severe disease versus lansoprazole at Week 24



    • New Drug Application (NDA) submission planned for H1 2022 targeting the following indications: healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn



    • Phathom to host conference call today, October 18, 2021, at 8:30 am ET

    FLORHAM PARK, N.J., Oct. 18, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal phase 3 trial evaluating vonoprazan versus lansoprazole for the treatment of erosive esophagitis. Based on the positive PHALCON-EE data, Phathom plans to submit an NDA to the U.S. Food and Drug Administration seeking the following indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn.

    "The PHALCON-EE results are a major milestone for Phathom and for the 20 million Americans suffering from erosive esophagitis. The results further solidify vonoprazan's potential to be the first major innovation in the U.S. and European GERD market in more than 30 years," said Terrie Curran, Phathom's President and Chief Executive Officer. "The results demonstrated that vonoprazan is superior to a standard of care PPI across a broad range of clinically relevant endpoints in the study, importantly including the maintenance of healing erosions at 24 weeks for all EE patients. We are excited about the potential for vonoprazan to satisfy the large unmet needs of so many patients and set a new treatment paradigm in EE. We thank the patients, physicians, and clinical sites who participated in the PHALCON-EE study during the height of the COVID-19 pandemic, and we look forward to submitting an NDA and, if approved, making this treatment available for EE patients."

    Study Design

    PHALCON-EE was a trial with two phases. In the first phase, vonoprazan 20 mg was compared to lansoprazole 30 mg in the healing of EE after up to 8 weeks of treatment (Healing Phase). In the Healing Phase, patients were assessed via endoscopy to determine complete healing following 2 weeks of treatment and, if complete healing was not achieved, a second endoscopy occurred at 8 weeks of treatment. Patients who achieved complete healing were re-randomized into the second phase of the trial, where vonoprazan 10 mg and 20 mg were compared to lansoprazole 15 mg to assess maintenance of healing via endoscopy following 24 weeks of treatment (Maintenance Phase). Heartburn symptom relief was assessed via secondary endpoints in both the Healing and Maintenance Phases of the study based on twice daily e-diary data collection.

    Study Results

    Healing Phase

    The primary endpoint of the Healing Phase was non-inferiority of vonoprazan 20 mg compared to lansoprazole 30 mg in the percentage of all patients who have complete healing of EE by Week 8. Vonoprazan met the Healing Phase primary endpoint with a healing rate of 93% compared to 85% for lansoprazole (p<0.0001). In a preplanned exploratory superiority test, the difference between vonoprazan and lansoprazole was also significant (p<0.0001).1

    Vonoprazan met the secondary superiority endpoint of healing in patients with moderate-to-severe disease2 at Week 2, demonstrating significantly faster healing than lansoprazole (70% for vonoprazan 20 mg and 53% for lansoprazole 30 mg) (p=0.0004). Vonoprazan 20 mg was also compared to lansoprazole 30 mg in a superiority test for onset of sustained resolution of heartburn by day 3 but did not achieve statistical significance (p=0.2196). In additional secondary endpoint superiority comparisons, vonoprazan 20 mg healing rates were numerically greater than lansoprazole 30 mg in all patients at Week 2 (p=0.0174)3 and in moderate-to-severe patients2 by Week 8 (p<0.0001)3 although deemed nominally significant due to the sequential testing method.

    Vonoprazan also met the secondary endpoint of showing non-inferiority to lansoprazole 30 mg in the mean percentage of 24-hour heartburn free days over the healing period.

    Maintenance Phase

    Vonoprazan met the primary and all secondary endpoints in the Maintenance Phase. The primary endpoint of the Maintenance Phase was non-inferiority of vonoprazan 10 mg and 20 mg compared to lansoprazole 15 mg in the percentage of all patients who maintained healing of EE through Week 24.

    Both vonoprazan doses met the Maintenance Phase primary endpoint of non-inferiority while also meeting the secondary comparison demonstrating superiority of maintenance of healing versus lansoprazole (79% for vonoprazan 10 mg, 81% for vonoprazan 20 mg compared to 72% for lansoprazole 15 mg) (p<0.0001 for both non-inferiority comparisons; p=0.0218 for vonoprazan 10 mg superiority comparison; p=0.0068 for vonoprazan 20 mg superiority comparison).

    Both vonoprazan doses also met the secondary endpoint of demonstrating superiority of the percentage of patients with moderate-to-severe disease4 who maintained healing of EE through Week 24 (75% vonoprazan 10 mg, 77% vonoprazan 20 mg v. 61% lansoprazole 15 mg) (p=0.0245 for vonoprazan 10 mg superiority comparison; p=0.0098 for vonoprazan 20 mg superiority comparison). Additionally, both vonoprazan doses also met the secondary endpoint of showing non-inferiority to lansoprazole 15 mg in the mean percentage of 24-hour heartburn free days over the maintenance period.

    Safety profile

    Overall, the safety results for vonoprazan observed in PHALCON-EE were consistent with the results observed in prior clinical studies.

    The most common reported adverse event in the Healing Phase was diarrhea (2.1% for vonoprazan 20 mg and 2.5% for lansoprazole 30 mg). The most commonly reported adverse events in the Maintenance Phase (>5%) were COVID-19 infection (10.1% vonoprazan 20 mg, 6.1% vonoprazan 10 mg, 6.7% lansoprazole 15 mg), gastritis (2.7% vonoprazan 20 mg, 6.4% vonoprazan 10 mg, 2.7% lansoprazole 15 mg), and abdominal pain (5.4% vonoprazan 20 mg, 4.1% vonoprazan 10 mg, 2.4% lansoprazole 15 mg).

    Frequency of serious adverse events (SAEs) in the Healing Phase were the same between vonoprazan 20 mg and lansoprazole 30 mg at 0.6%. In the Maintenance Phase, SAEs were reported in 4.7% of patients for vonoprazan 20 mg, 3.4% for vonoprazan 10 mg and 2.4% for lansoprazole 15 mg. COVID-19 infection was the only SAE reported in more than one patient per group. There were 7 COVID-19 SAEs across both phases of the study (5 on vonoprazan 20 mg and 2 on vonoprazan 10 mg). Two deaths occurred among the reported COVID-19 SAE cases. None of the COVID-19 SAEs were deemed related to the study drug by the investigator.

    "Today's results indicate an advancement in the treatment of erosive esophagitis," said Loren Laine, M.D., Professor of Medicine and Chief, Digestive Diseases at Yale School of Medicine, and lead investigator of the PHALCON-EE study. "The PHALCON-EE data support vonoprazan as a novel potential alternative to PPIs to improve healing and reduce recurrence of erosions in patients with erosive esophagitis."

    Phathom plans to present the full results from the PHALCON-EE study at a medical meeting next year and submit them for publication in a peer-reviewed journal.

    The positive PHALCON-EE data provides Phathom with access to an additional $50 million from its term loan facility with Hercules Capital. As of September 30, 2021, Phathom had approximately $225 million in available cash and cash equivalents, exclusive of the additional $50 million available from the term loan facility.

    Detailed PHALCON-EE Topline Data

    PHALCON-EE Topline Data
    Endpoints (Healing Phase)

    (n=1024*)
    Vonoprazan

    20 mg

    (n=514)
    Lansoprazole

    30 mg

    (n=510)
    P-Value

    (95%CI)
    A% of all patients healed by Week 893%85%p<0.00011



    [p<0.0001]2
     Mean % of 24-hour heartburn free days over the healing period67%64%-1.60, 7.035
     % of Grades C/D patients healed at Week 2 70%53%p=0.00043
     % of all patients with onset of sustained resolution of ​heartburn by Day 334%32%p=0.21963
     % of Grades C/D patients healed by Week 8 92%72%[p<0.0001]4
     % of all patients healed at Week 2 74%68%[p=0.0174]4
    Endpoints (Maintenance of Healing)Vonoprazan

    20 mg

    (n=291)
    Vonoprazan

    10 mg

    (n=293)
    Lansoprazole

    15 mg

    (n=294)
    P-Value

    (95%CI)

    vono 20 mg v.

    lanso 15 mg
    P-Value

    (95%CI)

    vono 10 mg v.

    lanso 15 mg
    A% of all patients maintained through Week 2481%79%72%p<0.00011



    p=0.00683
    p<0.00011



    p=0.02183
     % of Grades C/D ​patients maintained through Week 2477%75%61%p=0.00983p=0.02453
     Mean % of 24-hour heartburn free days through Week 2481%81%79%-2.63, 6.725-2.27, 6.845
    A primary endpoint

    1 non-inferiority comparison for primary endpoints

    2 exploratory superiority comparison, nominal p value presented

    superiority comparison

    superiority comparison, not significant based on pre-specified testing hierarchy, nominal p value presented

    5 non-inferiority comparison, non-inferiority margin 15%



    *34.3% of the 1024 patients were classified as having LA Grades C/D erosions

    Conference call on the PHALCON-EE trial results

    Phathom will host a webcasted conference call today, October 18, 2021, at 8:30 am ET to discuss the PHALCON-EE study results.

    To view the live webcast, visit https://investors.phathompharma.com/news-events/events-and-presentations. Please log in approximately 10 minutes prior to the scheduled start time.

    A replay of the webcast and the slide presentation will be available after the meeting on the News & Events section of the Phathom website.

    About Erosive Esophagitis

    Erosive Esophagitis (EE) is a major type of gastroesophageal reflux disease (GERD) characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus. There are estimated to be over 65 million individuals with GERD in the U.S., of which approximately 30% have EE. In addition to experiencing troubling heartburn symptoms, patients with inadequately treated EE may progress to more severe diseases including Barrett's esophagus and esophageal cancer.

    About PHALCON-EE

    PHALCON-EE was a randomized, double-blind, two-phase, multicenter, Phase 3 trial that enrolled 1,024 patients with EE in the U.S. and Europe. The first phase of the trial evaluated the efficacy and safety of vonoprazan 20 mg administered once-daily (QD) compared to lansoprazole 30 mg QD for the healing of EE for up to eight weeks. The second phase of the trial evaluated the efficacy and safety of vonoprazan 10 mg QD and 20 mg QD compared to lansoprazole 15 mg QD for the maintenance of healing of EE for 24 weeks. Both phases also evaluated heartburn symptoms.

    About Vonoprazan

    Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has awarded qualified infectious disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom submitted NDAs in September 2021 to the FDA for vonoprazan-based regimens for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.

    About Phathom

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com and follow the Company on LinkedIn and Twitter.

    Forward Looking Statement

    The financial results included in this press release are unaudited and preliminary estimates that (i) represent the most current information available to management as of the date of this press release, (ii) are subject to completion of financial closing and procedures that could result in significant changes to the estimated amounts, and (iii) do not present all information necessary for an understanding of Phathom's financial condition as of, or its results of operations for the quarter ended, September 30, 2021. Accordingly, undue reliance should not be placed on such preliminary estimates.

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected submission of an NDA for healing and maintenance of healing of erosive esophagitis and heartburn symptom relief and the Company' ability to access capital under its term loan facility. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: reported top-line data is based on preliminary analysis of key efficacy and safety data is subject to more audit and verification procedures that could result in material changes in the final data; we may experience delays submitting the NDA including in the event that the FDA does not agree with the Company's interpretation of the data or feedback from the FDA that may be inconsistent with feedback received at prior meetings with the FDA; Phathom's ability to access additional capital under the term loan facility is subject to certain conditions including verification by the lender that the clinical milestone has been met; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom's QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    media@phathompharma.com

    Investor Contact:

    Joe Hand

    1-877-742-8466

    ir@phathompharma.com

    1 Exploratory superiority comparison, nominal p value presented

    2 Patients with moderate-to-severe disease relates to patients with esophageal erosions classified as Grades C or D by the Los Angeles (LA) Classification System

    3 Superiority comparison, not tested due to the pre-specified testing hierarchy, nominal p value presented

    4 Patients with moderate-to-severe disease in the Maintenance Phase refers to patients who entered the Healing Phase of PHALCON-EE with esophageal erosions classified as Grades C or D by the LA Classification System



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  2. Vonoprazan 20 mg demonstrated significantly greater acid suppressive effects over the 7-day study period compared to lansoprazole (PREVACID®) 30 mg, a proton pump inhibitor (PPI)

    FLORHAM PARK, N.J., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported results from VONO-103, a Phase 1 trial evaluating the effects of vonoprazan 20 mg once daily ("QD") and lansoprazole 30 mg QD in healthy U.S. subjects. In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole. The study treatments were generally well tolerated with no…

    Vonoprazan 20 mg demonstrated significantly greater acid suppressive effects over the 7-day study period compared to lansoprazole (PREVACID®) 30 mg, a proton pump inhibitor (PPI)

    FLORHAM PARK, N.J., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported results from VONO-103, a Phase 1 trial evaluating the effects of vonoprazan 20 mg once daily ("QD") and lansoprazole 30 mg QD in healthy U.S. subjects. In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole. The study treatments were generally well tolerated with no serious adverse events reported.

    The primary pharmacodynamic endpoints of VONO-103 were mean gastric pH over twenty-four hours ("mean 24-hour pH value") and the percentage of time with gastric pH above 4 (pH>4 holding time ratio or "pH>4 HTR") on Days 1 and 7. Gastric pH levels are measured on a logarithmic scale from 0.0 to 14.0, in which each point represents a 10-fold change in acidity and higher pH values represent lower acidity.

    Following the first dose, the mean 24-hour gastric pH value on Day 1 for vonoprazan was 4.6 as compared to 2.8 for lansoprazole (p<0.0001). The least squares mean pH>4 HTR on Day 1 for vonoprazan was 62.2% as compared to 23.2% for lansoprazole.1  

    The greater gastric acid inhibition was maintained after seven days of once daily dosing. The mean 24-hour pH value on Day 7 for vonoprazan was 5.9 as compared to 3.8 for lansoprazole (p<0.0001). The least squares mean pH>4 HTR on Day 7 was 86.8% for vonoprazan as compared to 42.1% for lansoprazole.1

    "Acid suppression has been shown to be an important factor in the treatment of acid-related gastrointestinal disorders," said Eckhard Leifke, M.D., Chief Medical Officer of Phathom. "We are very pleased with today's results, as they demonstrate that vonoprazan provides more powerful gastric acid suppression after both one day and seven days of once daily administration as compared to the PPI, lansoprazole."

    VONO-103 is the first pharmacokinetic and pharmacodynamic (PK/PD) and safety study comparing vonoprazan 20 mg QD and lansoprazole 30 mg QD. Phathom is also currently conducting PHALCON-EE, a Phase 3 study in patients with erosive esophagitis, comparing vonoprazan and lansoprazole in both healing and maintenance of healing of erosions, as well as the relief of heartburn. Topline results of PHALCON-EE are expected in October 2021.

    About VONO-103

    VONO-103 is a Phase 1, open-label, randomized, 2-period crossover study evaluating the PK/PD profile and safety and tolerability of vonoprazan 20 mg QD in comparison to lansoprazole 30 mg QD, in healthy subjects. Lansoprazole 30 mg QD is the approved dose for "short term treatment of erosive esophagitis (EE)" – an 8-week course of treatment for healing of EE. In each period of the VONO-103 study, doses of either vonoprazan 20 mg or lansoprazole 30 mg were administered once daily (QD) for 7 consecutive days. Gastric pH was measured continuously over a 24-hour period at baseline and on Days 1 and 7 of Periods 1 and 2. Between periods there was a seven-day wash out. The study was conducted in a study center in the U.S. The primary pharmacodynamic endpoints were mean gastric pH over 24 hours and the percentage of time with gastric pH >4 (pH>4 holding time ratio or "pH>4 HTR") on Days 1 and 7.

    About Vonoprazan

    Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has awarded qualified infection disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom submitted new drug applications in September 2021 to the U.S. FDA for vonoprazan-based regimens for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.

    About Phathom

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at www.phathompharma.com or follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    Forward Looking Statements

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected availability of topline results from the PHALCON-EE Phase 3 clinical trial. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to accept or approve the NDAs; the inherent risks of clinical development of vonoprazan; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    media@phathompharma.com

    Investor Contact:

    Joe Hand

    1-877-742-8466

    ir@phathompharma.com

    _____________________

    1
    The least squares mean difference in pH>4 HTR on Days 1 and 7 for vonoprazan vs. lansoprazole was 39.0% [95% confidence interval (CI): 31.9-46.0; p<0.0001] and 44.6% [95% CI: 37.6-51.7; p<0.0001], respectively. 



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  3. FLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported it has obtained a $200 million term loan facility from Hercules Capital, Inc. (NYSE:HTGC), a leader in customized debt financing for companies in life sciences and technology-related markets. This additional capital further strengthens Phathom's balance sheet in advance of anticipated key catalysts, including data from the pivotal PHALCON-EE Phase 3 trial of vonoprazan for the treatment of erosive esophagitis in October 2021, data from the Phase 2 trial of vonoprazan for the treatment of non-erosive…

    FLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported it has obtained a $200 million term loan facility from Hercules Capital, Inc. (NYSE:HTGC), a leader in customized debt financing for companies in life sciences and technology-related markets. This additional capital further strengthens Phathom's balance sheet in advance of anticipated key catalysts, including data from the pivotal PHALCON-EE Phase 3 trial of vonoprazan for the treatment of erosive esophagitis in October 2021, data from the Phase 2 trial of vonoprazan for the treatment of non-erosive reflux disease in the first quarter of 2022, and FDA approval and commercial launch of vonoprazan-based regimens for the treatment of H. pylori in the second half of 2022. This non-dilutive financing extends Phathom's projected cash runway to mid-2023 based on the Company's current operating plans.

    "Vonoprazan has the potential to become the first innovative treatment for patients with acid-related disorders approved in the US in more than thirty years," said Terrie Curran, President and Chief Executive Officer of Phathom. "This non-dilutive $200 million term loan facility significantly strengthens our balance sheet ahead of vonoprazan's potential US commercial launch and provides Phathom with additional financial flexibility as we continue to work to change the landscape for patients with gastrointestinal diseases."

    "Hercules is proud to partner with Phathom ahead of several important milestones as they advance their vonoprazan development programs and prepare for a potential commercial launch," said Bryan Jadot, Senior Managing Director and Life Sciences Group Head at Hercules Capital. "The substantial capital commitment from Hercules aims to help Phathom deliver on their important mission to improve the lives of people suffering from acid related gastrointestinal diseases and reflects our dedication to financing promising life science companies," added Lake McGuire, Managing Director at Hercules Capital.

    Under the terms of the $200 million term loan facility, $100 million was drawn at closing, and an additional $100 million becomes available in two tranches of $50 million each. The first $50 million tranche becomes available upon the receipt of positive data from the PHALCON-EE Phase 3 trial. The second $50 million tranche becomes available upon the occurrence of both FDA approval of a vonoprazan-based regimen for the treatment of H. pylori and FDA acceptance of filing of a new drug application for vonoprazan for the treatment of erosive esophagitis. Approximately $54 million of the initial $100 million drawn down by the Company will be used to pay off the principal of the Company's existing outstanding term loan. The new facility provides for an interest-only period of three years, which is extendable based on the achievement of certain regulatory milestones. The loan facility is secured by the Company's assets.

    Armentum Partners acted as the Company's exclusive financial advisor on this transaction.

    Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K.

    About Phathom

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at  www.phathompharma.com or follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    Forward Looking Statements

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential acceptance and approval by the FDA of our NDAs for vonoprazan; our plans to commercially launch vonoprazan in the second half of 2022; and our anticipated cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to accept or approve the NDAs; the inherent risks of clinical development of vonoprazan; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    media@phathompharma.com

    Investor Contact:

    Joe Hand

    1-877-742-8466

    ir@phathompharma.com



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  4. FLORHAM PARK, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it has submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori (H. pylori) infection in adults. With current standard of care therapies, H. pylori eradication rates have declined in the U.S. If approved, vonoprazan-based treatments offer two…

    FLORHAM PARK, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it has submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori (H. pylori) infection in adults. With current standard of care therapies, H. pylori eradication rates have declined in the U.S. If approved, vonoprazan-based treatments offer two new therapeutic options that have demonstrated superior eradication rates as compared to standard of care lansoprazole-based triple therapy.  

    "The submission of these NDAs is the first step towards addressing the declining H. pylori eradication rates in the U.S. and providing new potential treatment options for the millions of H. pylori sufferers in need of more efficacious treatments," said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. "Today's announcement underscores Phathom's commitment to changing the treatment landscape for acid-related diseases. If approved, patients and healthcare providers would have two novel options to combat this highly prevalent bacterial infection. We look forward to working with the FDA to advance these vonoprazan-based treatment regimens toward approval. If approved, we anticipate launch in the U.S. in the second half of 2022."

    These NDAs are based on the positive data previously announced from Phathom's pivotal Phase 3 PHALCON-HP trial, the largest U.S. registrational trial ever conducted for H. pylori. The study evaluated eradication rates of H. pylori infection using vonoprazan triple therapy and vonoprazan dual therapy compared to lansoprazole-based triple therapy. Vonoprazan triple therapy and vonoprazan dual therapy successfully met the study's primary non-inferiority endpoints and all secondary endpoints, demonstrating superior eradication rates versus lansoprazole-based triple therapy among all patients including in patients with clarithromycin resistant strains of H. pylori.

    The FDA has previously designated vonoprazan triple therapy and vonoprazan dual therapy as qualified infectious disease products (QIDP) and awarded them Fast Track designation, in each case, for the treatment of H. pylori infection. In connection with the NDA submissions, Phathom requested Priority Review, which, if granted, will shorten the review period from 10 months to 6 months following FDA acceptance of the submissions for filing.

    About Helicobacter pylori (H. pylori) infection

    H. pylori is a bacterial pathogen that is estimated to infect over 200 million individuals in the United States and Europe. Approximately 50% of the world and 36% of the US population are infected with the bacterium.1 In many cases, H. pylori is acquired in childhood and through intrafamilial transmission.2 As a result of the chronic inflammation induced by H. pylori infection, infected patients develop a range of pathologies including dyspepsia, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma.3 Studies have found that roughly 1 in 5 patients treated for H. pylori will fail first line therapy when using standard clarithromycin triple therapy.2,4  

    About PHALCON-HP

    PHALCON-HP was a randomized, multicenter, Phase 3 trial that enrolled 1046 patients of which 992 patients with a confirmed H. pylori infection were randomized to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID) (n=324); vonoprazan 20 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=338); and lansoprazole 30 mg BID, amoxicillin 1g BID and clarithromycin 500 mg BID (n=330). Each treatment regimen was administered for 14 days. Diagnoses of infection and test of cure were confirmed by 13C-urea breath test. Additional efficacy analyses were conducted using the pre-specified per protocol population (n=822), a subset of the mITT population comprised of patients who were protocol compliant.

    About Vonoprazan

    Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has awarded qualified infection disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.

    About Phathom

    Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information about Phathom, visit the Company's website at  www.phathompharma.com or follow the Company on social media: LinkedIn at www.linkedin.com/company/phathompharma and Twitter @PhathomPharma.

    Forward Looking Statements

    Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential acceptance and approval by the FDA of our NDAs for vonoprazan; the ability of vonoprazan-based treatments to address declining H. pylori eradication rates; and our plans to commercially launch vonoprazan in the second half of 2022. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom's business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to accept or approve the NDAs; the inherent risks of clinical development of vonoprazan; Phathom's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom's ability to obtain and maintain intellectual property protection for vonoprazan; Phathom's ability to comply with its license agreement with Takeda; Phathom's ability to maintain undisrupted business operations due to the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.


    1 Hooi et al. Gastroenterology. 2017;153:420.

    2 Chey et al. Am J Gastroenterol.2017;112:212.

    3 Malfertheiner et al. Gut. 2017;66:6.

    4 Alsamman et al. Dig Dis Sci. 2019;64:2893.

    CONTACTS

    Media Contact:

    Nick Benedetto

    1-877-742-8466

    media@phathompharma.com

    Investor Contact:

    Joe Hand

    1-877-742-8466

    ir@phathompharma.com



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