AZRX AzurRx BioPharma Inc.

1.44
-0.07  -5%
Previous Close 1.51
Open 1.5
52 Week Low 0.370868
52 Week High 2.63
Market Cap $76,922,945
Shares 53,418,712
Float 52,431,246
Enterprise Value $79,014,568
Volume 1,369,256
Av. Daily Volume 9,538,930
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Upcoming Catalysts

Drug Stage Catalyst Date
MS1819 - OPTION 2
Cystic fibrosis
Phase 2b
Phase 2b
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MS1819 + PERT combination
Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Oral niclosamide
COVID-19
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.

Latest News

  1. DELRAY BEACH, Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the appointment of James Sapirstein, President and CEO, as chairman of the company's board of directors, effective immediately. Mr. Sapirstein succeeds Mr. Edward J. Borkowski, who joined the AzurRx board in May 2015 and has served as chairman since April 2016. Mr. Borkowski will remain as lead independent director of the board of directors.

    "AzurRx is on the verge of several important inflection points, and I am pleased to take on additional responsibilities…

    DELRAY BEACH, Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the appointment of James Sapirstein, President and CEO, as chairman of the company's board of directors, effective immediately. Mr. Sapirstein succeeds Mr. Edward J. Borkowski, who joined the AzurRx board in May 2015 and has served as chairman since April 2016. Mr. Borkowski will remain as lead independent director of the board of directors.

    "AzurRx is on the verge of several important inflection points, and I am pleased to take on additional responsibilities at this exciting stage in the company's evolution," said Mr. Sapirstein. "I look forward to working with Ed and the other Board members to propel a business and clinical strategy that, I believe, has the potential to transform AzurRx and generate substantial value for the company and our shareholders.  I look forward to advancing the clinical programs for our lead investigational candidate, MS1819, and our novel niclosamide therapies to rapidly deliver safe and efficacious product candidates to patients who need them the most."

    Mr. Sapirstein added, "On behalf of the Board, I want to express my appreciation to Ed for his years of service to AzurRx. Under his dedicated stewardship, AzurRx has advanced its mission to develop world-class medicines that address serious disease-related GI complications. I am grateful for all that Ed has contributed to AzurRx and look forward to his ongoing input as a member of the Board and our lead independent director."

    "Having served on AzurRx's Board since 2015, I am committed to ensuring a prosperous future for the company," stated Mr. Borkowski. "Under James' leadership, AzurRx has strategically expanded its existing pipeline to pursue new opportunities in the treatment of gastrointestinal conditions. The recent licensing agreement with First Wave Bio represents an exciting new chapter in the company's growth with the potential to generate both near-term and long-range returns for AzurRx shareholders. James has been instrumental in implementing this strategy, and he is ideally suited to lead the company as both Chairman and CEO as we seek to maximize the full potential of AzurRx's pipeline and advance our clinical development programs."

    About James Sapirstein

    James Sapirstein was named President and Chief Executive Officer of AzurRx Therapeutics in October 2019 Mr. Sapirstein arrived at AzurRx from ContraVir Pharmaceuticals, Inc. (now known as Hepion Pharmaceuticals, Inc.), where he served as chief executive officer and board member. His career in the pharmaceutical industry has spanned nearly 37 years with extensive expertise in drug development and commercialization. Mr. Sapirstein has participated in 23 product launches, including six global launches that he led, and headed numerous business development transactions. Prior to ContraVir, Mr. Sapirstein served as CEO of Alliqua Therapeutics, as the founding CEO of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology for Serono Laboratories. Mr. Sapirstein has also held senior level positions at Gilead, Bristol Myers Squibb and Hoffmann-LaRoche. Mr. Sapirstein currently sits on the boards of Marizyme, Leading Biosciences and Enochian Biosciences. He also sits on the board on the Biotechnology Innovation Organization's (BIO) Emerging Companies Board and serves as Chairman Emeritus of BioNJ. Mr. Sapirstein earned a B.S. in Pharmacy from Rutgers University and received an MBA in Management from Fairleigh Dickinson University.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials.  AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

    Forward-Looking Statement

    This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    1615 South Congress Avenue

    Suite 103

    Delray Beach, Florida 33445

    Phone: (646) 699-7855

    Media contact:

    Tiberend Strategic Advisors, Inc.

    Johanna Bennett/Ingrid Mezo

    (212) 375-2665/(646) 604-5150

    /

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: (617) 430-7578 

      



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  2. DELRAY BEACH, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer, will present at The Microcap Rodeo Winter Wonderland Conference taking place virtually from February 16-19, 2021.

    During his live virtual presentation on February 17th at 4:30 p.m., Eastern Time, Mr. Sapirstein will provide an overview of AzurRx's business and clinical development programs and discuss anticipated 2021 milestones. Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one…

    DELRAY BEACH, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer, will present at The Microcap Rodeo Winter Wonderland Conference taking place virtually from February 16-19, 2021.

    During his live virtual presentation on February 17th at 4:30 p.m., Eastern Time, Mr. Sapirstein will provide an overview of AzurRx's business and clinical development programs and discuss anticipated 2021 milestones. Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one meetings with registered investors.

    Details of the presentation are as follows:

    Event: The Microcap Rodeo Winter Wonderland Conference
    Date:  February 17, 2021
    Time: 4:30 p.m. Eastern Time
    Registration:

     https://microcaprodeo.com/signup

    Presentation: https://www.webcaster4.com/Webcast/Page/2134/40075
       

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI clinical programs. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida. with clinical operations in Hayward, California. For more information visit www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    1615 South Congress Avenue

    Suite 103

    Delray Beach, Florida 33445

    Phone: (646) 699-7855

     

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: (617) 430-7578 

     

    Media contact:

    Tiberend Strategic Advisors, Inc.

    Johanna Bennett/Ingrid Mezo

    (212) 375-2665/(646) 604-5150

    /  



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  3. Phase 2 Study of oral niclosamide planned for 1H 2021

    DELRAY BEACH, Fla., Feb. 09, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has entered into an agreement with PPD, Inc. (NASDAQ:PPD), a leading global contract research organization (CRO), for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal (GI) infections.  

    Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule…

    Phase 2 Study of oral niclosamide planned for 1H 2021

    DELRAY BEACH, Fla., Feb. 09, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX), ("AzurRx" or the "Company"), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has entered into an agreement with PPD, Inc. (NASDAQ:PPD), a leading global contract research organization (CRO), for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal (GI) infections.  

    Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022. Licensed by AzurRx in January from FirstWave Bio, Inc., the goal of AzurRx's FW-1022 clinical program is to develop a safe, effective, non-systemic treatment for GI infections related to COVID-19. AzurRx anticipates initiating the trial in the first half of 2021.

    "We are moving rapidly to initiate the planned Phase 2 trial of FW-1022 and are pleased to have PPD as our CRO partner given the company's proven expertise and track record of clinical excellence," said James Sapirstein, President and CEO of AzurRx BioPharma. "Even as the vaccine rollout continues, millions of people will become infected with the SARS-CoV-2 virus, and recent study data suggest approximately 1 in 5 of those stricken will suffer COVID-related GI infections with symptoms that include loss of appetite, nausea, vomiting and diarrhea. There is no therapeutic available to treat this condition, and we believe FW-1022 offers the potential to address this serious and possibly long-lasting after-effect of COVID-19."

    Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, stated, "PPD is pleased to support AzurRx's efforts to bring relief to patients suffering from COVID-19-related GI infections. We recognize the breakthrough nature of AzurRx's work with FW-1022 and look forward to applying our capabilities and expertise to the development of FW-1022, beginning with the planned Phase 2 clinical trial."

    About COVID-19 Gastrointestinal Infections

    Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases1. Of the 26.6 million individuals who are reported to have contracted COVID-19 in the U.S., this would translate into 4.8 million patients having GI infection. Of the 105 million cases globally, it would translate into almost 19 million patients.

    There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.

    About Niclosamide

    Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.  In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.

    There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.2 Additionally, emerging evidence confirms the severe GI-related complications of COVID and potential fecal spread of the virus. The Company's clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.

    FW-1022

    FW-1022 is a niclosamide based small molecule which the Company's clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 will be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-1022 has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials.  AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

    About PPD

    PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppd.com.

    Forward-Looking Statement

    This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    1615 South Congress Avenue

    Suite 103

    Delray Beach, Florida 33445

    Phone: (646) 699-7855

    Media contact:

    Tiberend Strategic Advisors, Inc.

    Johanna Bennett/Ingrid Mezo

    (212) 375-2665/(646) 604-5150

    /

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: (617) 430-7578 

    1 Gut Journal: Vol 69, Issue 6: 2020; Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020

    2 Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.



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  4. DELRAY BEACH, Fla., Feb. 08, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer, will present at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021. The presentation will be available on demand during the virtual event for all registered attendees.

    During the presentation, Mr. Sapirstein will provide an overview of the Company's business and clinical development programs and discuss anticipated 2021 milestones.   Additionally, Mr. Sapirstein and members of the AzurRx management team will…

    DELRAY BEACH, Fla., Feb. 08, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer, will present at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021. The presentation will be available on demand during the virtual event for all registered attendees.

    During the presentation, Mr. Sapirstein will provide an overview of the Company's business and clinical development programs and discuss anticipated 2021 milestones.   Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one meetings with registered investors and pharmaceutical companies.

    Details of the event are as follows:

     Event:BIO CEO & Investor Digital Conference
     Date: February 16-18, 2021
     Registration:https://www.bio.org/events/bio-ceo-investor-digital-conference/registration-categories
       

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI clinical programs. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida. with clinical operations in Hayward, California. For more information visit www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead, represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial; and the Company's success in raising additional financing to support its operations. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    1615 South Congress Avenue

    Suite 103

    Delray Beach, Florida 33445

    Phone: (646) 699-7855

     

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: (617) 430-7578 

     

    Media contact:

    Tiberend Strategic Advisors, Inc.

    Johanna Bennett/Ingrid Mezo

    (212) 375-2665/(646) 604-5150

    /  



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  5. DELRAY BEACH, Fla., Jan. 28, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced the completion of patient enrollment in the first cohort of the Phase 2b OPTION 2 extension study evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

    The Phase 2b OPTION 2 trial extension arm is currently dosing patients at clinical trial sites in the U.S. and Europe who have participated in the previous arms of the OPTION 2 trial. The goal of the MS1819 clinical program is to provide cystic…

    DELRAY BEACH, Fla., Jan. 28, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced the completion of patient enrollment in the first cohort of the Phase 2b OPTION 2 extension study evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

    The Phase 2b OPTION 2 trial extension arm is currently dosing patients at clinical trial sites in the U.S. and Europe who have participated in the previous arms of the OPTION 2 trial. The goal of the MS1819 clinical program is to provide cystic fibrosis patients with a safe and effective therapy to control EPI, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can lead to a chronic nutritional deficiency. For cystic fibrosis patients, maintaining proper nutritional levels is essential to ensure healthy growth, weight management and good lung function.

    James Sapirstein, President and Chief Executive Officer of AzurRx BioPharma, stated, "The extension arm of the Phase 2b OPTION 2 trial is providing us with an opportunity to determine both the optimized dosage and delivery mechanism of MS1819. We have fully enrolled the most important cohort of the extension study and would like to thank both our clinical collaborators and patients for their continued participation in the study. We continue to be encouraged by the absence of any reports of serious adverse events to date, and eagerly look forward to reporting topline results from this trial in Q1 2021."

    OPTION 2 Extension Study

    The Phase 2b OPTION 2 study is an open-label, multi-center, crossover clinical trial designed to investigate the safety, tolerability, and efficacy of MS1819 in a head-to-head comparison against the current standard of care for EPI, porcine pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint is the coefficient of fat absorption (CFA). AzurRx BioPharma initiated the additional study arm, the Phase 2b OPTION 2 extension trial, to identify both the optimal dose and the optimal delivery method for MS1819 using immediate-release capsules at higher dose levels than previous early-stage clinical trials.

    To date, there have been no serious adverse events reported during either the Phase 2b OPTION 2 trial or its extension arm. The Phase 2b OPTION 2 extension trial is enrolling volunteers 18 years or older at trial sites in the U.S. and Poland who have completed the OPTION 2 crossover trial at higher dose levels relative to the previous OPTION 1 trial. Trial participants will be treated with MS1819 over a two-week-period. AzurRx BioPharma expects to report topline data by the end of first quarter 2021.

    About MS1819

    MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral, non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, porcine pancreatic enzyme replacement therapy (PERT), the MS1819 synthetic lipase does not contain any animal products. The global market for PERT was estimated to be approximately $1.4 billion in the U.S. and more than $2 billion globally in 2019. There currently is no non-animal-based enzyme replacement therapy in the market for the treatment of exocrine pancreatic insufficiency. AzurRx believes that MS1819 has the potential to provide a safe and effective non-animal derived, or synthetic, alternative to PERT, without the risk of animal pathogen transmission or fibrosing colonopathy. In addition, we believe that MS1819 has the potential to improve patient compliance and quality of life given anticipated reductions in pill burden and pill size relative to PERT.

    About Exocrine Pancreatic Insufficiency

    EPI is a condition characterized by a deficiency of the exocrine pancreatic enzymes, resulting in a patient's inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge, and weight loss.

    There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI clinical programs. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida. with clinical operations in Hayward, California. For more information visit www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead, represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial; and the Company's success in raising additional financing to support its operations. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    1615 South Congress Avenue

    Suite 103

    Delray Beach, Florida 33445

    (646) 699-7855

     

    Investor Relations contact:

    LifeSci Advisors, LLC 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    (617) 430-7578 

     

    Media contact:

    Tiberend Strategic Advisors, Inc.

    Johanna Bennett/Ingrid Mezo

    (212) 375-2665/(646) 604-5150

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