• Globally recognized experts in cystic fibrosis and chronic pancreatitis care and research to support AzurRx in advancing the clinical development of MS1819

NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced the formation of a Scientific Advisory Board (SAB) including three of the leading global experts in exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.

“We are thrilled to have this distinguished group of scientific leaders helping to guide our research and clinical development efforts as we advance our MS1819 program for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis patients,” said James Sapirstein, Chief Executive Officer of AzurRx.

Dr. James Pennington, Chief Medical Officer of AzurRx added, “We are proud to have attracted this illustrious team of experts to our SAB. Their deep expertise and insights will be invaluable as we continue progressing our clinical program in exocrine pancreatic insufficiency (EPI) from Phase 2 to a pivotal Phase 3 clinical trial.”

The AzurRx SAB members will include:

Michael Konstan, M.D. is Vice Dean for Translational Research and the Gertrude Lee Chandler Tucker Professor of Pediatrics at Case Western Reserve University School of Medicine, and the Austin Ricci Chair in Pediatric Pulmonary Care and Research at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, OH. Dr. Konstan has spent his entire professional career in the care and research of people with cystic fibrosis (CF). He has led numerous national and international clinical trials of potentially new therapies for CF, and his seminal work has led to several therapies that are in use today, including the only therapy recommended in guidelines for treating the lung inflammation in CF using high doses of ibuprofen. Dr. Konstan was the first recipient of the Cystic Fibrosis Foundation’s Harry Shwachman Clinical Investigator Award, and later in his career he received the Richard C. Talamo Distinguished Clinical Achievement Award from the Foundation. He has published extensively in the medical literature with more than 200 peer-reviewed publications, nearly all related to cystic fibrosis. He has served on multiple advisory boards and committees for the CF Foundation, the NIH and the FDA, all related to advancing the treatment of CF. He currently serves on the CF Foundation’s Clinical Research Executive Committee. Dr. Konstan received his bachelor’s and medical degrees from Case Western Reserve University (CWRU). After completing his internship and residency in Pediatrics at The Children’s Hospital of Buffalo, he returned to CWRU and Rainbow Babies and Children’s Hospital for Fellowship training in Pediatric Pulmonology.

Darwin L. Conwell, M.D. is a physician-scientist in gastroenterology specializing in pancreas disorders and currently Professor of Medicine with tenure at The Ohio State University College of Medicine where he serves as Director of the Division of Gastroenterology, Hepatology and Nutrition at The Ohio State Wexner Medical Center. He is an NIH-funded physician-scientist with over 200 peer reviewed publications. He has achieved extramural funding from the NIH-NIDDK, NCI, NIH-CATS, Harvard Digestive Disease Center, American College of Gastroenterology, ChiRhoClin, Inc., Solvay Pharmaceuticals and the National Pancreas Foundation.  He is a member of the NIDDK/NCI U01 Chronic Pancreatitis, Diabetes and Pancreas Cancer (CPDPC) Consortium, where he serves as the PI for The Ohio State Clinical Center. He also is a member of the NIDDK U01 Type 1 Diabetes Acute Pancreatitis Consortium, where he serves as a multi-PI.  Dr. Conwell is the former holder of the Charles Austin Doan Chair in Medicine and currently is the Floyd Beman Endowed Chair in Gastroenterology. Dr. Conwell is active in numerous gastrointestinal societies and is former President of The American Pancreatic Association.  He has served on several committees and boards at the American College of Gastroenterology and American Pancreatic Association. Dr. Conwell received a Bachelor of Science in Chemistry with Honors from Ohio University, Medical Degree from the University of Cincinnati College of Medicine and a Master’s Degree in Clinical Research from the University of Michigan.  Dr. Conwell completed internship and residency at The Christ Hospital in Cincinnati, Ohio and gastroenterology fellowship at the Cleveland Clinic Foundation. Dr. Conwell served as faculty at Cleveland Clinic for 15 years and started the Pancreas Clinic.  He later served on staff at Brigham and Women’s Hospital in Boston as an Associate Professor of Medicine at Harvard Medical School.

Michael Wilschanski, M.D. is Director of Pediatric Gastroenterology at Hadassah Hebrew University Medical Center. He has led numerous national and international studies of potentially new therapies in CF. He is the Director of the Electrophysiology Laboratory in Hadassah where he performs in vivo and in vitro measurements of electrolyte transport which is used diagnostically and therapeutically in CF. He is the past Chairman of the European Cystic Fibrosis Society Diagnostic Network, and past Chairman of ESPGHAN (European Society of Pediatric Gastroenterology, Hepatology and Nutrition) Working Group on Cystic Fibrosis and Pancreatic Disease. He is recipient of numerous international research grant to investigate pancreatic disease in children including a collaborative study from the NIH and has published nearly 150 articles extensively on all aspects of pediatric gastroenterology. Dr Wilschanski graduated from the University of London (Royal Free Medical School) and completed his Pediatric residency at Shaare Zedek Hospital in Jerusalem. He completed his 3-year fellowship in pediatric gastroenterology at The Hospital for Sick Children in Toronto, Canada. Dr. Wilschanski returned to Israel and worked as a senior pediatric gastroenterologist at Shaare Zedek before being appointed Director of Pediatric Gastroenterology Unit at the Hadassah University Hospitals (Ein Kerem and Mount Scopus) in 2003.

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, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency

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

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at 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. 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.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
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 

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