First Wave BioPharma Announces AAPS 2022 PharmSci 360 Accepts Adrulipase Formulation Summary

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First Wave BioPharma, Inc.

Research focuses on microgranule delivery formulations for adrulipase

BOCA RATON, Fla., Aug. 31, 2022 (GLOBE NEWSWIRE) — First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company developing of Targeted and Non-Systemic Therapies for Gastrointestinal (GI) Diseases, today announced that an abstract entitled “Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase” has been accepted at AAPS 2022 PharmSci 360. conference will be October 16-19 at the Boston Convention & Exhibit Center.

The abstract will detail research involving several spray-dried dispersion formulations (microgranules) of adrulipase, an investigational treatment for pancreatic exocrine insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). First Wave BioPharma and its drug formulation partner, Pace® Life Sciences, have developed a technology for Adrulipase that provides an optimal delayed release profile that can significantly increase the drug load of Adrulipase capsules designed to deliver active lipase to targeted areas of the gastrointestinal tract (GI ).

“We are very pleased that First Wave and Pace®Research from on the development of a microgranule delivery formulation for adrulipase has been accepted for presentation at the AAPS 2022 PharmSci 360 conference,” said James Sapirstein, President and CEO of First Wave BioPharma. “Previous clinical studies of adrulipase suggest that the drug is effective in treating EPI, but the ability to consistently deliver the drug to the small intestine at therapeutically relevant levels has presented a challenge. We are delighted to report that an optimal formulation of microgranules has been developed, and we now look forward to launching a clinical trial using this formulation this year.

A white paper detailing First Wave BioPharma’s progress in developing the microgranule formulation for Adrulipase 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 the yeast Yarrowia lipolytica lipase and is designed to break down fat molecules in the digestive tract of patients with EPI so that 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.
Rhythm® makes the world a safer and healthier place. Rhythm® people are committed to advancing the science of our customers in the pharmaceutical and biopharmaceutical industries. The therapies that our customers develop improve the lives of patients and we are committed to supporting them in all phases of development. Through our nationwide network of world-class CDMO and CRO sites, Pace® supports customers from the initial phase of R&D through the production of clinical trial materials and ongoing GMP laboratory support of commercial products. For our customers with in-house manufacturing facilities and labs, Pace® provides a wide range of professional services to advance their operations. 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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