First Wave BioPharma Announces Initial Clinical Sites for its Phase 2 Trial of Enhanced Microgranule Delivery Formulation of Adrulipase
BOCA RATON, Fla., Dec. 05, 2022 (GLOBE NEWSWIRE) -- 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, announced today that it has selected the initial clinical trial sites for its planned Phase 2 clinical trial to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Based on anticipated regulatory and clinical trial activities, First Wave BioPharma expects to report topline data from the Phase 2 trial by mid-2023.
In coordination with its contract research organization (CRO) partner, Rho, First Wave BioPharma has secured cooperation from the following investigators and research centers:
Dr. Steven Boas, M.D.
Dr. Daniel Layish, M.D.
Dr. Craig Nakamura, M.D.
First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia. During the meetings, there was consensus among the investigators that the enhanced formulation of adrulipase has the potential to overcome key challenges associated with commercial pancreatic enzyme replacement therapy (PERT), which is the current standard of care for EPI.
“Exocrine pancreatic insufficiency is a common ailment associated with cystic fibrosis and chronic pancreatitis. Currently available therapies, such as PERT, are able to manage the symptoms of the disease but require patients to take as many as 40 capsules per day. This ‘pill burden’ presents a substantial challenge for EPI patients,” said Dr. Steven Boas, M.D, founder of the Cystic Fibrosis Institute and Cystic FibrosisCenter of Chicago. “We are hopeful that this enhanced formulation of adrulipase will be able to address the symptoms of EPI while also providing a more convenient dosing option for patients.”
“We believe that our reformulation of adrulipase offers the potential to provide a dramatically improved treatment option for EPI patients,” said James Sapirstein, President and CEO of First Wave BioPharma. “We look forward to proceeding with this important trial.”
About First Wave BioPharma, Inc.
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