AzurRx BioPharma (NASDAQ: AZRX) this morning said it has submitted an Investigational Medicinal Product Dossier (IMPD) for MS1819-SD. The company’s lead product, currently under development as part of a join research and development agreement with Laboratoires Mayoly Spindler, SAS, is a recombinant lipase for the treatment of exocrine pancreatic insufficiency caused by chronic pancreatitis and cystic fibrosis. Prior to opening clinical centers in France as part of the company’s ongoing clinical study, the IMPD was submitted for approval through the European Medicines Agency clinical trial portal. Among other information, the IMPD includes data from clinical and non-clinical studies, and information regarding the quality, manufacture and control of MS1819-SD. “This IMPD submission reflects the continued geographic expansion of our MS1819-SD clinical trial program and upon approval will allow us to open clinical trial sites in France,” AzurRx BioPharma CEO Thijs Spoor stated in the news release.
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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
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