AzurRx BioPharma Announces First Three Patients Included in Phase IIa Study with MS1819-SD for Endocrine Pancreatic Insufficiency

BROOKLYN, N.Y., Dec. 21, 2016 -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company, that the first three patients in the Phase IIa clinical trial with MS1819-SD for patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) have been enrolled.

The open-label, dose escalation Phase II study is being conducted in two sites in Australia, The Royal Adelaide Hospital and Linear Clinical Research in Perth, as well as two sites in New Zealand, P3 Research in Wellington and CCST in Christchurch.  The study is projected to complete 12-15 patients with EPI caused by chronic pancreatitis over the next several months. 

The primary objective of this Phase II study is to investigate the safety of escalating doses of MS1819-SD in patients with CP. The secondary objective is to investigate the efficacy dose response of MS1819-SD in these patients by analysis of the coefficient of fat absorption (CFA) and its change from baseline. Safety will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests.

The Company anticipates reporting data periodically during this trial, with results from  the first group of patients enrolled expected to be reported in the first half of 2017.

Thijs Spoor, President and CEO of AzurRx, said “The enrollment of the first patient/first patients in our Phase II study is a significant milestone in the clinical development of MS1819. We look forward to further demonstrating MS1819’s effect in reducing the conditions associated with chronic pancreatitis and improving the lives of EPI patients. 

“We are excited to play an instrumental role in helping to develop new therapies for a range of human conditions” said Dr. Richard Stubbs, Managing Director of P3 Research, in Wellington, New Zealand. “We are committed to being a leader in trialling medicines that have significant potential to change patient care.”

MS1819-SD, an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowica lipolytica lipase, and is entirely plant-based/vegan. In early animal and human trials, it has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency of this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

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 cystic fibrosis 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 2015 was estimated to be $820 million in the U.S. and $1.5 billion globally according to Wall Street estimates.

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 750 people worldwide.

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

About Endocrine Pancreatic Insufficiency:

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

About MS1819

MS1819-SD, supplied as an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products. In an animal model, the in-vivo activity of MS1819 was superior to the activity seen in-vivo using the standard of care porcine pancreatic extracts.  A previous study has found that MS1819 was well tolerated in humans with no serious adverse events.
Information about the trial can be found on the following website: 
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ms1819&isBasic=True

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigations Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

For more Information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 217 
Brooklyn, NY 11226
Phone: 646.699.7855
http://www.azurrx.com  [email protected]

For more Information:
Laboratories Mayoly Spindler
6 Avenue de l'Europe
B.P. 51 - 78401 
CHATOU Cedex - France
Phone: +33(0)1 34 80 57 00
Fax: + 33(0)1 34 80 41 11
http://www.mayoly-spindler.com  [email protected]