AzurRx BioPharma and Mayoly-Spindler Announce Positive MS1819-SD Phase II Data in Exocrine Pancreatic Insufficiency (EPI)

BROOKLYN, NY, USA I September 27, 2017 I AzurRx BioPharma Inc.(NASDAQ:AZRX) (“AzurRx” or the “Company”), today provided an update on the first six treated patients in its ongoing Phase IIa trial of MS1819-SD, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis.

Importantly, the company observed both clinical activity and a clear dose response, where the highest MS1819-SD dose cohort showed greater than 21% improvement in CFA (coefficient of fat absorption) in evaluable patients.  Additionally, maximal absolute CFA response to treatment was up to 57%, with an inverse relationship to baseline CFA. Favorable trends were also observed on other evaluated endpoints, such as Bristol stool scale, number of daily evacuations and weight of stool, and these were consistent with the CFA results.

With regard to safety, no serious adverse events or notable mild to moderate events have been reported in the open-label, ascending dose Phase IIa trial.  Other markers relating to nutritional status including patients’ plasma albumen were unchanged with treatment.  Similarly, fecal nitrogen assessments showed favorable trends.

“We are encouraged by these Phase IIa data,” said Thijs Spoor, CEO of AzurRx BioPharma.  “They further confirm the activity of MS1819-SD and also demonstrate its dose response characteristics.  Additionally, secondary efficacy endpoints are consistently aligning with the CFA data and the safety profile of MS1819-SD remains favorable.”

Phase IIa Study
The open-label, dose escalation Phase IIa study is being conducted in Australia and New Zealand and has been designed to enroll 12-15 patients with EPI caused by chronic pancreatitis.

The primary objective of the Phase IIa study is to investigate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary objective is to investigate the efficacy of MS1819-SD in these patients by analysis of the coefficient of fat absorption and its change from baseline. Safety is being assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests.

About MS1819, a Recombinant Lipase

MS1819, a recombinant lipase derived from the yeast Yarrowia Lipolytica, is in development for the treatment of exocrine pancreatic insufficiency (EPI) associated with chronic pancreatitis (CP) and cystic fibrosis (CF).  Early Phase Ib data in EPI patients treated with MS1819 showed a favorable safety profile and encouraging preliminary signals of efficacy.

There are approximately 100,000 patients in the U.S. with EPI caused by CP according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills. The U.S. market for such EPI porcine replacement therapy pills in 2016 was estimated to be approximately $950 million in the U.S. and $1.5 billion globally according to IMS data and Wall Street estimates.

AzurRx and Laboratoires Mayoly Spindler are party to a joint research and development agreement and are collaborating on the development of a yeast derived recombinant lipase for the oral treatment of Exocrine pancreatic insufficiency (EPI).  Under terms of their partnership agreement, AzurRx has marketing rights for the recombinant Lipase in various geographies, including exclusive rights for North America.

About AzurRx BioPharma, Inc.:

AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819 recombinant lipase for exocrine pancreatic insufficiency is the company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the company can be found at www.azurrx.com

About Laboratoires Mayoly Spindler, SAS

Mayoly Spindler is a French, independent, family-owned pharmaceutical company, active in research, development, manufacturing, registration and marketing of pharmaceuticals and dermo-cosmetics in more than 70 countries. The company aims to become a global reference in gastroenterology and dermocosmetics. Mayoly Spindler is headquartered in the Paris area of France, and employs 800 people worldwide.

Mayoly Spindler website address: www.mayoly-spindler.com

SOURCE: AzurRx BioPharma

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