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. 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.
Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago
Northfield, IL

Dr. Daniel Layish, M.D.
Central Florida Pulmonary Group
Orlando, FL

Dr. Craig Nakamura, M.D.
Children's Lung Specialists
Las Vegas, NV

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 Fibrosis Center 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 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 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