AzurRx Announces Manufacturing Agreement with Delpharm for MS1819 Clinical Drug Product

NEW YORK, April 16, 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 that it has entered into a manufacturing agreement with Delpharm (“Delpharm”), a leading contract development manufacturing organization (CDMO), for the clinical drug product supply of its MS1819 therapy for exocrine pancreatic insufficiency (EPI). 

Under the terms of the agreement, Delpharm will manufacture AzurRx’s MS1819 cGMP batch that will be used in the Phase 2b OPTION 2 Clinical Trial for the treatment of EPI in patients with Cystic Fibrosis (CF).  As preparation for the cGMP batch, the drug product manufacturing process was transferred to Delpharm and they have successfully produced a non-GMP batch.  This marks the first time in which MS1819 has been manufactured with enteric capsules, which will be used in the OPTION 2 Trial to deliver MS1819 drug product during the duodenal phase of digestion.

“We are very pleased to have Delpharm continue to be our MS1819 manufacturing partner as we prepare for the launch of our OPTION 2 Clinical Trial,” said James Sapirstein, CEO of AzurRx BioPharma. “We greatly appreciate Delpharm’s commitment to continue working through the COVID-19 pandemic to produce our clinical study drug product, which will enable us to meet our planned timelines and initiate the study in Q2 2020, as expected.”

“Delpharm is very proud to play a role in supporting AzurRx’s clinical trial and helping cystic fibrosis patients gain access to this promising new treatment,” added Sébastien Aguettant, CEO of Delpharm.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). 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
Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by a deficiency of the pancreatic digestive enzymes in the intestinal tract needed to breakdown the nutrients in food so that they can be properly absorbed.  This deficiency results in abdominal discomfort and pain, frequent bowel movements, steatorrhea, poor fat absorption, weight loss and chronic malnutrition.