First Wave BioPharma, Inc. provided an update on its adrulipase (FW-EPI) clinical program and advances involving adrulipase. Adrulipase is a recombinant lipase enzyme derived from the Yarrowia lipolytica yeast that First Wave BioPharma is developing for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. First Wave BioPharma has filed two new provisional patent applications pertaining to adrulipase with the U.S. Patent and Trademark Office (USPTO).

The first application is directed to new lipase dosage forms, methods of treatment and methods of manufacturing. The Company anticipates using these dosage forms in a Phase 2b monotherapy trial in 2H 2022. The second, application expands the potential indications for adrulipase to new patient populations based on adrulipase's potential to improve the nutritional status of individuals who may benefit from additional absorption of nutrients.

Any resultant patent claiming priority to these two provisional patent filings will have an estimated term to 2042. In separate news, First Wave BioPharma has received formal approval from the World Health Organization (WHO) for the use of “adrulipase alfa” as the International Nonproprietary Name (INN) for the drug (formerly MS1819). First Wave BioPharma is pursuing parallel monotherapy and combination therapy clinical pathways with adrulipase.

The Company reported topline results in 2021 from two Phase 2 clinical trials. The new oral formulation of adrulipase, now in development, is planned to be administered with food as a capsule that dissolves in the stomach and disperses acid-resistant micro-granules that thoroughly mix with food during the digestion process. The resultant mixture then passes to the small intestine where the lipase enzyme breaks up fat molecules so that they can be absorbed.

The Company expects to complete the formulation work in the first half of 2022 and to initiate a Phase 2b monotherapy trial during the second half of 2022.