Benzinga | Jan 13, 2022 11:45AM EST

First Wave BioPharma Provides Update On Adrulipase Clinical Program

First Wave BioPharma, Inc., (NASDAQ:FWBI), ("First Wave BioPharma" or the "Company"), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today 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.

"This is an important step in our efforts to strengthen and expand our adrulipase intellectual property portfolio as we advance the FW-EPI clinical development program," said James Sapirstein, President and CEO of First Wave BioPharma. "Data from the Combination Trial study and other completed clinical trials in chronic pancreatitis and cystic fibrosis patients have provided insights to potentially inform and expand the use case for adrulipase."

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).

"The WHO's approval of adrulipase alfa as the International Nonproprietary Name affirms that this drug technology is unique in design and nature, and, given the advanced stage of clinical development in the FW-EPI program, should be clearly distinguished from other pharmaceutical products," stated Mr. Sapirstein. "An INN, also referred to as a generic name, facilitates the identification of pharmaceutical substances or active pharmaceutical ingredients and is an essential component to a drug's product label. The assignment of adrulipase alpha to the FW-EPI clinical program provides an additional point of differentiation as we continue the drug's development as a potential treatment for EPI that could improve upon the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT)."

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.