First Wave BioPharma Finalizes Adrulipase Microgranule Drug Delivery Formulation Selection

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First Wave BioPharma, Inc.

Data suggests the technology provides an enhanced delayed release profile that ensures adrulipase is delivered to targeted areas of the gastrointestinal tract

First Wave BioPharma Plans to Initiate a Phase 2 Trial of “Optimized Adrulipase” Before the End of 2022

BOCA RATON, Fla., Sept. 07, 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 non-systemic targeted therapies for gastrointestinal (GI) diseases, today announced the selection of an enhanced enteric microgranule-based drug delivery formulation for the ongoing development of its clinical adrulipase program (FW-EPI). First Wave BioPharma now plans to submit an Investigational New Drug (IND) amendment to the U.S. Food & Drug Administration (FDA) for a “proof-of-concept” Phase 2 clinical study of the optimized version of adrulipase as a treatment for chronic exocrine pancreas (IPE) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). First Wave BioPharma expects to initiate the Phase 2 trial before the end of 2022 after IND acceptance.

In vitro data suggests that the new formulation provides a delayed release profile which should ensure adrulipase is protected in the stomach and delivered to targeted areas of the gastrointestinal tract, allowing adrulipase to mix with food in the duodenum where it can then provide its therapeutic effect. This improvement should translate into consistent Fat Absorption Coefficient (FFA) values ​​above 80%. A CFA greater than 80% is the recognized threshold for obtaining therapeutic benefit in patients with EPI associated with cystic fibrosis and CP.

Additionally, research indicates that the improved formulation has the potential to significantly reduce the number of pills a patient would need to take to achieve the desired therapeutic effect. The pill load associated with pancreatic enzyme replacement therapy (PERT) can be as high as 40 capsules per day, which presents a considerable challenge for patients with EPI. The ability to reduce pill count while maintaining efficacy is seen as a key differentiator for patients. Additionally, First Wave BioPharma has identified manufacturing improvements that can reduce cost of goods by significantly increasing production yields.

“The selection of enteric microgranule-based drug delivery technology follows extensive research by First Wave BioPharma and our drug delivery formulation partner, Pace® Life Sciences, into the development and manufacturing of the optimized adrulipase formulation,” said James Sapirstein, President and CEO of First Vague BioPharma. “We are pleased to report that the new formulation of adrulipase outperformed previous versions of the drug in every measure, and we look forward to evaluating this potential in a proof-of-concept Phase 2 clinical trial, which we plan to conduct. launch before the end of the year. . Our hope is that with this improved formulation, we come one step closer to improving the lives of patients with exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.

Research involving the optimized formulation of adrulipase will be the subject of a poster presentation at AAPS 2022 PharmSci 360 to be held in Boston October 16-19, 2022. (“Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase”). Additionally, First Wave BioPharma previously published a white paper detailing the development of the microgranule formulation for Adrulipase. The white paper is available on the company’s website at the following URL: Adrulipase White Paper

About Adrulipase
Adrulipase is a recombinant lipase enzyme administered as a non-systemic oral biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from Yarrowia lipolytica yeast lipase and is designed to break down fat molecules in the digestive tract of EPI patients so they can be absorbed as nutrients. EPI is a condition characterized by a deficiency of exocrine pancreatic enzymes, resulting in the patient’s inability to digest food properly or poor digestion. Deficiency in this enzyme can be responsible for fatty diarrhea, fecal urges and weight loss. According to the Cystic Fibrosis Foundation, there are more than 30,000 patients in the United States with EPI caused by cystic fibrosis and approximately 90,000 patients in the United States 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 focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with several clinical-stage programs built around its two proprietary technologies – biological 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). By developing Adrulipase, First Wave seeks to provide CF and CP patients with a safe and effective therapy to control EPI that is not of animal origin and has the potential to significantly reduce their daily pill burden. . The company is also advancing several programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative rectosigmoiditis, 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.

About the rhythm® Life Sciences, Inc.
Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting and facilities support services to the pharmaceutical, biopharmaceutical and gene therapy industries from our network of CDMO sites , GMP analytical testing laboratories and manufacturing support. service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities underscore our commitment to effectively advancing client programs from clinic to commercialization. We are committed to providing the best and most reliable services with positive customer experiences across all channels of our business. A subsidiary of Pace® Science and Technology Company, Pace® Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and manufacturing and regulatory support service centers across the United States. . More at pacelifesciences.com.

Forward-looking statement
This press release may contain certain statements regarding future results that are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, perhaps materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors, including whether results obtained in preclinical studies and non-clinical and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results of a clinical trial will be indicative of the final results of the trial; the size of potential markets for the Company’s drug candidates and its ability to serve those markets; the effects of the acquisition of First Wave Bio, Inc. and its announcement on the Company’s business, results of operations and financial outlook; the integration of the First Wave Bio, Inc. business with the Company’s own business; and the Company’s current and future capital requirements and its ability to raise additional funds to meet its capital requirements. Additional information regarding the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, is contained in the Company’s Annual Report on Form 10-K for the fiscal 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 undertake no obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that occur subsequently or of which we become aware subsequently.

For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, Florida 33431
Phone: (561) 589-7020
[email protected]

Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia
(609) 468-9325
[email protected]

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