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AzurRx BioPharma (AZRX) And Mayoly Spindler Announce Initiation Of Phase II Clinical Trial Of MS1819-SD For Exocrine Pancreatic Insufficiency In Chronic Pancreatitis Patients



11/17/2016 7:45:55 AM

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BROOKLYN, N.Y., Nov. 17, 2016 (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, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company, the initiation of a Phase II clinical trial evaluating the safety and efficacy of MS1819-SD in patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP).

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 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 enroll approximately 12 patients with EPI caused by chronic pancreatitis over the next several months.  Dr. Quoc Nam Ngyuen, Associate Professor in the Department of Gastroenterology at the Royal Adelaide Hospital is the principal investigator for the study.

The primary objective of this Phase II 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 will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests. Initial study results from the MS1819-SD Phase II study are expected in the first half of 2017.

"Today's announcement marks another step forward for AzurRx in helping to define the future for treating patients with exocrine pancreatic insufficiency,” said Thijs Spoor, President and CEO of AzurRx.  “We are very pleased that our Phase II trial for MS1819 will be developed with such prestigious institutions. We believe that non-systemic therapies have the ability to make significant improvements in patients living with a variety of diseases where selective targeting of the therapy while specifically avoiding non-target organs will provide physicians around the world with meaningful improvements in patient care and will provide patients with innovative therapies designed to improve their quality of life."

“We are very pleased to begin this phase IIa dose escalation trial. We strongly believe that such a product could have a significant improvement for the treatment of Exocrine Pancreatic Insufficiency,” stated Stephane Thiroloix, Mayoly Spindler Laboratories’ CEO. 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, Mayoly Spindler granted AzurRx 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, France, and employs 750 people worldwide.
Company 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 of 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 similar 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 regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships.  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.


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