Research involves 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 specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that an abstract titled, “Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase,” has been accepted at AAPS 2022 PharmSci 360. The conference will be held Oct. 16-19 at the Boston Convention & Exhibit Center.

The abstract will detail research involving multiple spray dried dispersion (microgranule) delivery formulations of adrulipase, an experimental treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). First Wave BioPharma, and its drug delivery formulation partner, Pace® Life Sciences, have been developing a technology for adrulipase that provides an optimal, delayed-release profile that enables significantly increased drug loading of adrulipase capsules designed to deliver active lipase within the targeted areas of the gastrointestinal (GI) tract.

“We are very pleased that First Wave and Pace®’s research into the development of a microgranule delivery formulation for adrulipase was accepted for presentation at the AAPS 2022 PharmSci 360 conference,” said James Sapirstein, President and CEO of First Wave BioPharma. “Prior clinical studies of adrulipase suggest the drug is effective at treating EPI, however the ability to consistently deliver the drug to the small intestine at therapeutically relevant levels has presented a challenge. We are excited to report that an optimal microgranule formulation has been developed, and we now look forward to initiating a clinical trial utilizing this formulation this year.”

A white paper detailing First Wave BioPharma’s progress in the development of the microgranule formulation for adrulipase is available on the company’s website via the following URL:

Adrulipase White Paper

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

About Pace® Life Sciences, Inc.
Pace® makes the world a safer, healthier place. Pace® people are committed to advancing the science of our customers in the pharmaceutical and biopharmaceutical industries. The therapies our customers develop improve patient lives and we are committed to supporting them through all phases of development. Through our nationwide network of world-class CDMO and CRO sites, Pace® supports customers from early-phase R&D to clinical trial materials production and ongoing commercial product GMP laboratory support. For our customers with manufacturing facilities and in-house labs, Pace® provides a wide range of professional services to keep their operations moving forward. More at

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; 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 and its announcement on the Company’s business, operating results and financial prospects; 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 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

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

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777 Yamato Road
Suite 502
Boca Raton, FL 33431
(561) 589-7020