First Wave BioPharma Inc FWBI has filed two new provisional patent applications on adrulipase with the U.S. Patent and Trademark Office (USPTO).
- The first application is directed to new lipase dosage forms, treatment methods, and manufacturing. The second application expands the potential indications for adrulipase to new patient populations.
- Any resultant patent claiming priority to these two provisional patent filings will have an estimated term to 2042.
- Related: First Wave BioPharma Stock Jumps On Niclosamide's Favorable Safety Profile In COVID-19 Related GI Infections.
- Adrulipase is a recombinant lipase enzyme derived from the Yarrowia lipolytica yeast under development for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis.
- 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 for the drug (formerly MS1819).
- First Wave BioPharma is pursuing parallel monotherapy and combination therapy clinical pathways with adrulipase.
- The new oral formulation of adrulipase, now in development, will 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 Company expects to complete the formulation work in 1H of 2022 and initiate a Phase 2b monotherapy trial during 2H of 2022.
- Price Action: FWBI shares are up 6.85% at $1.56 during the premarket session on the last check Thursday.
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