AzurRx BioPharma (AZRX), Mayoly Spindler Initiatie MS1819-SD Phase 2 in CP-Related EPI

November 17, 2016 7:48 AM EST

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AzurRx BioPharma Inc. (Nasdaq: AZRX) announced 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.

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