AzurRx BioPharma, Inc. announced the World Health Organization (WHO) has published “adrulipase alfa” as the proposed International Nonproprietary Name (INN) for MS1819. MS1819 is a recombinant lipase enzyme that is currently under development for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. AzurRx is pursuing parallel monotherapy and combination therapy clinical pathways with MS1819.

The Company reported topline results from its Phase 2b OPTION 2 monotherapy trial in March 2021 and expects to report full topline results from its Phase 2 combination therapy trial, evaluating MS1819 in combination with PERT, for the treatment of severe EPI in patients with cystic fibrosis, in the third quarter of 2021. The WHO is expected to render a final decision on the use of adrulipase alfa for MS1819 by November 2021. MS1819 is a recombinant lipase enzyme that has been developed for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.

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 lipase does not contain any animal products.