TRVI Trevi Therapeutics Inc.

3.05
-0.04  -1%
Previous Close 3.08
Open 3.13
52 Week Low 1.33
52 Week High 8.5
Market Cap $56,061,410
Shares 18,380,790
Float 5,569,750
Enterprise Value $17,492,737
Volume 30,485
Av. Daily Volume 21,883
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Upcoming Catalysts

Drug Stage Catalyst Date
Nalbuphine ER - PRISM
Prurigo Nodularis
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
Nalbuphine ER
Chronic cough - Idiopathic pulmonary fibrosis (IPF)
Phase 2
Phase 2
Phase 2 trial has restarted following halt due to COVID-19 - October 21, 2020.

Latest News

  1. PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis 

    Exceeds Halfway Enrollment Milestone

    Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject Post-COVID-19 Restrictions

    Cash Position Expected to Fund Operations into the First Half of 2022

    NEW HAVEN, Conn., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2020, as well as business updates.

    "We are pleased with the continued progress of our clinical development programs," said Jennifer…

    PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis 

    Exceeds Halfway Enrollment Milestone

    Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject Post-COVID-19 Restrictions

    Cash Position Expected to Fund Operations into the First Half of 2022

    NEW HAVEN, Conn., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2020, as well as business updates.

    "We are pleased with the continued progress of our clinical development programs," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We recently announced significant developments in both of our ongoing clinical trials by surpassing halfway enrollment in our PRISM trial and enrolling the first new subject in our chronic cough trial in IPF since the study resumed after pausing due to COVID restrictions. We are focused on completing enrollment in both trials and preparing for the next steps in the development of Haduvio."

    Key Business Updates

    • Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: The Company has enrolled approximately 190 subjects in the trial and reaffirms its guidance that it expects to complete enrollment in the third quarter of 2021 and to report top-line data in the fourth quarter of 2021.



    • Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Company resumed screening and enrolling patients in the trial following the pause in the trial due to COVID-19. The Company amended the study protocol to require fewer in-person visits by subjects as well as fewer procedures in order to facilitate the completion of the trial in an at-risk patient population for COVID-19. Additionally, the Company is assessing additional study sites in Germany which could potentially accelerate enrollment and reduce the risks inherent with single-country recruitment during the COVID-19 pandemic.

    Third Quarter 2020 Financial Highlights

    Cash position: As of September 30, 2020, the Company had total cash and cash equivalents of $53.3 million, compared to $57.3 million as of December 31, 2019. During the third quarter of 2020, the Company received $14.0 million in proceeds from a term loan with Silicon Valley Bank and sold approximately $2.5 million of common stock under the Company's ATM program. The Company expects its cash position will fund operations into the first half of 2022.

    Research and development (R&D) expenses: R&D expenses for the third quarter of 2020 were $4.8 million compared to $5.7 million in the same period in 2019. The decrease was primarily due to decreased activity in the Company's Phase 2 trial in chronic cough in patients with IPF due to the pausing of enrollment and treatment of patients as a result of the COVID-19 pandemic as well as decreased activity with the completion of the Company's Phase 1b trial in patients with chronic liver disease.

    General and administrative (G&A) expenses: G&A expenses for the third quarter of 2020 were $2.4 million compared to $2.0 million in the same period in 2019. The increase was primarily due to an increase in stock-based compensation expenses and an increase in consulting fees.

    Net loss: For the third quarter of 2020, the Company reported a net loss of $7.4 million, compared to a net loss of $7.4 million in the same period in 2019.

    Conference Call

    As previously announced, the Company will host a conference call and webcast today, November 11, 2020 at 4:30 p.m. ET. To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.         

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on Trevi's clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

    (unaudited)

    (amounts in thousands)

     September 30,

    2020
     December 31,

    2019
        
    Cash and cash equivalents$53,293 $57,313
    Working capital 49,106 54,353
    Total assets 55,879 60,001
    Total debt 13,798 ──
    Stockholders' equity 35,618 54,545

    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2020 2019 2020 2019
            
    Operating expenses:       
    Research and development$4,828  $5,650  $15,768  $14,516 
    General and administrative 2,416   2,000   7,528   5,363 
    Total operating expenses 7,244   7,650   23,296   19,879 
    Loss from operations (7,244)  (7,650)  (23,296)  (19,879)
    Other income (expense), net (145)  280   26   352 
    Loss before income tax benefit (7,389)  (7,370)  (23,270)  (19,527)
    Income tax benefit 11   5   35   14 
    Net loss$(7,378) $(7,365) $(23,235) $(19,513)

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    Primary Logo

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  2. NEW HAVEN, Conn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020.

    Presentation Time: 10:00 a.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following…

    NEW HAVEN, Conn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020.

    Presentation Time: 10:00 a.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    Primary Logo

    View Full Article Hide Full Article
  3. NEW HAVEN, Conn., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on November 11, 2020, to provide a corporate update and review the Company's financial results for the third quarter ended September 30, 2020.

    To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News' section on the…

    NEW HAVEN, Conn., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on November 11, 2020, to provide a corporate update and review the Company's financial results for the third quarter ended September 30, 2020.

    To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    Media Contact  

    Rosalia Scampoli

    914-815-1465

            

    Primary Logo

    View Full Article Hide Full Article
  4. Restart of Phase 2 Clinical Trial of Haduvio for Chronic Cough in Patients with IPF

    Phase 2b/3 PRISM Trial of Haduvio for Severe Pruritus in Patients with Prurigo Nodularis Reaches 50% Enrollment Milestone

    NEW HAVEN, Conn., Oct. 21, 2020 (GLOBE NEWSWIRE) --  Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today, announced updates to their ongoing clinical trials of Haduvio. Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a trial that was paused due to IPF patients being an at-risk population…

    Restart of Phase 2 Clinical Trial of Haduvio for Chronic Cough in Patients with IPF

    Phase 2b/3 PRISM Trial of Haduvio for Severe Pruritus in Patients with Prurigo Nodularis Reaches 50% Enrollment Milestone

    NEW HAVEN, Conn., Oct. 21, 2020 (GLOBE NEWSWIRE) --  Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today, announced updates to their ongoing clinical trials of Haduvio. Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a trial that was paused due to IPF patients being an at-risk population for COVID-19. In addition, the Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis, randomized its 180th subject, officially reaching 50% enrollment.

    Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in patients with IPF that is being conducted in the United Kingdom (UK). The study is designed to enroll approximately 60 subjects with a goal to have 44 study completers. The primary endpoint for the study is the mean percent change in daytime cough frequency as measured by a cough monitor. The study will also examine various secondary endpoints.

    Professor Toby Maher, based at the Royal Brompton Hospital and the lead investigator for this Phase 2 trial, said, "I am pleased to see Trevi's trial for chronic cough in IPF patients restart screening after pausing due to the COVID-19 pandemic. IPF is a debilitating disease, with chronic cough being a significant contributor to a patient's reduced quality of life. Nalbuphine ER is of particular interest for the clinical treatment of chronic cough due to the potential of its mixed agonist/antagonist mechanism of action."

    "The Company has worked with Dr. Maher to amend the protocol to require fewer in-person visits by the subjects as well as fewer procedures," said Dr. Thomas Sciascia, Trevi's Chief Medical Officer. "We believe this better protects the overall safety of these patients during the time of the pandemic."

    The amended protocol was recently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and patient screening has restarted at certain sites in the UK. Additionally, Trevi is analyzing the possible addition of study sites in Germany to potentially accelerate enrollment and mitigate the COVID-related risks inherent to recruitment from a single-country.

    Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis:

    During October, the PRISM trial randomized its 180th subject into the study, reaching 50% enrollment of the expanded trial size following the sample size re-estimation completed in July. We expect to complete enrollment in the PRISM trial in the third quarter of 2021 and report top-line data in the fourth quarter of 2021.

    "We are pleased with the continued progress of our clinical development programs in these two severe conditions," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We have seen continued momentum in the enrollment in the PN trial and look forward to helping the remaining clinical sites for cough in IPF get restarted."

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on our clinical trials, business and operations, the expected timing of enrollment and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; the expected timing of milestones for the Company's other ongoing and planned clinical trials; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy, including to enroll patients in the anticipated timeframes; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating our cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    Media Contact  

    Rosalia Scampoli

    914-815-1465

            

    Primary Logo

    View Full Article Hide Full Article
  5. NEW HAVEN, Conn., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Shashank Rohatagi, Ph.D., as Vice President, Pharmacology and Clinical Pharmacokinetics, Farrell Simon, Pharm.D., as Vice President, Head of U.S. Marketing, and Katherine S. Takaki, Ph.D., as Vice President, Global Regulatory Affairs. Dr. Rohatagi will be responsible for managing the supportive studies required to seek regulatory approvals as well as all CMC-related activities, and joins Trevi after senior roles at Metrum Research, Otsuka Pharmaceuticals…

    NEW HAVEN, Conn., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Shashank Rohatagi, Ph.D., as Vice President, Pharmacology and Clinical Pharmacokinetics, Farrell Simon, Pharm.D., as Vice President, Head of U.S. Marketing, and Katherine S. Takaki, Ph.D., as Vice President, Global Regulatory Affairs. Dr. Rohatagi will be responsible for managing the supportive studies required to seek regulatory approvals as well as all CMC-related activities, and joins Trevi after senior roles at Metrum Research, Otsuka Pharmaceuticals and Daiichi Sankyo. Dr. Simon will lead the development and implementation of the commercial strategy for Haduvio, and joins Trevi from Pfizer. Dr. Takaki will oversee Trevi's global regulatory strategies including interactions with key regulatory authorities and leading any registration efforts for Haduvio, and joins the Company after working at Iterum Therapeutics and Bristol Myers Squibb.

    "We are pleased to welcome Shashank, Farrell, and Kathy to our management team as we move forward with Haduvio," said Jennifer L. Good, President and Chief Executive Officer. "Their extensive backgrounds in various areas of the biopharmaceutical industry should be invaluable to the success of Trevi as we continue to advance Haduvio. We look forward to their insight as we work towards providing treatment to those suffering from serious conditions, such as chronic pruritus in patients with prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis which currently have no approved therapies."

    Dr. Rohatagi brings his diverse experience in the pharmaceutical industry and drug development to the Trevi team. As Senior Principal Scientist for Clinical Pharmacology at Metrum Research Group, he was responsible for providing strategic and operational support for clinical pharmacology and regulatory issues across therapeutic areas for various stages of drug development. Prior to that, Dr. Rohatagi was Vice President of Data Sciences at Otsuka managing the group that supported data analytics for all phases of development and regulatory submissions. Dr. Rohatagi holds a Ph.D. from the University of Florida in Pharmacokinetics/Pharmacodynamics and an M.B.A from St. Joseph's University.

    Dr. Simon has a diverse set of experiences he brings to Trevi to develop and execute commercialization plans for Haduvio. His career spans both U.S. and global roles, where he has developed and implemented numerous marketing and sales campaigns to increase internal and external engagement. He is an experienced general manager who has successfully led operating plans for brands of varying size and worked across the lifecycle of products from in-line brands to early commercial development assets. Prior to joining Trevi, Dr. Simon most recently served as Chief of Staff to the Group President of Biopharma at Pfizer and was a member of the leadership team. In this role he led operations across seven innovative business units, as well as led pan-business unit strategic initiatives. He began his career at Procter & Gamble and holds both an M.B.A. and a Pharm.D. from the University of Florida.

    Dr. Takaki joins Trevi with extensive pharmaceutical industry experience in regulatory strategy, global project and team management, and drug discovery. Before becoming part of Trevi, she served as Vice President, Global Regulatory Affairs at Iterum Therapeutics where she helped build out the regulatory group to support the company's regulatory strategy and operations. Prior to that, Dr. Takaki held leadership positions at Bristol Myers Squibb supporting multiple therapeutic areas. She was the global project manager for the team that developed Baraclude for the treatment of hepatitis B and launched it in markets worldwide. Her most recent role at Bristol Myers was Group Director, Head of Regulatory Strategy Marketed Products. She holds a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology and a B.S. in Chemistry from the University of Hawaii at Manoa.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding potential regulatory submissions; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating our cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    Media Contact

    Rosalia Scampoli

    914-815-1465

            

     

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