First Wave BioPharma Provides Update on IND Filing For Phase 2 Trial of Enhanced Microgranule Formulation of Adrulipase for Exocrine Pancreatic Insufficiency
First Wave BioPharma (NASDAQ:FWBI) announced that the FDA is reviewing its IND amendment for a Phase 2 clinical trial of an enhanced microgranule formulation of adrulipase to treat exocrine pancreatic insufficiency (EPI) related to cystic fibrosis and chronic pancreatitis. The amendment was submitted on November 30, 2022, and a response is expected by the end of January 2023. The company is prepared to start the trial immediately upon FDA clearance. Adrulipase is designed to help patients digest fats, addressing a significant health issue for the over 120,000 EPI patients in the U.S. The CEO expressed optimism about the FDA's supportive interactions.
- FDA is currently reviewing the IND amendment for Phase 2 clinical trial.
- The company expects FDA's response by the end of January 2023.
- Successful trial could address a significant health need for over 120,000 EPI patients in the U.S.
- Interactions with the FDA have been supportive of First Wave's clinical plans.
- The IND amendment review could take longer than the anticipated 60 days.
- There are inherent risks in clinical trials that may affect the company's financial condition.
BOCA RATON, Fla., Jan. 13, 2023 (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 that the U.S. Food and Drug Administration (FDA) is reviewing the Investigational New Drug (IND) amendment for the planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) as an IND protocol amendment. Under FDA’s policy guidelines, the agency strives to complete its review of Phase 2 protocols within 60 days, but may take longer depending on available resources. The Company previously announced that it submitted the IND amendment to the FDA on November 30, 2022. First Wave BioPharma has been in conversations with FDA and expects a forthcoming response around the end of January.
“We are eager to evaluate the potential of our enhanced microgranule delivery formulation of adrulipase in the proof-of-concept Phase 2 clinical trial, which we are prepared to initiate immediately after the IND protocol amendment is cleared,” said James Sapirstein, President and CEO of First Wave BioPharma. “Interactions with the FDA have thus far been supportive of our clinical plan, and we are working closely with our CRO partner and the clinical trial sites to begin enrolling patients as soon as we are able.”
About Adrulipase
Adrulipase is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss. There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation.
About First Wave BioPharma, Inc.
First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple clinical stage programs built around its two proprietary technologies – the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties. First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). In developing adrulipase, First Wave is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden. The company is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn’s disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com.
Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the contemplated offering will be successful and whether the Company will be able to regain and maintain compliance with Nasdaq’s continued listing criteria; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@firstwavebio.com
Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia
(609) 468-9325
dschemelia@tiberend.com
Bill Borden
(732) 910-1620
bborden@tiberend.com
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