First Wave BioPharma Provides Update on Adrulipase (FW-EPI) Clinical Program

• Company filed two provisional patent applications for new enteric granule formulation of adrulipase and for related nutritional indications in new patient populations

• “Adrulipase Alfa” approved by World Health Organization (WHO) as International Nonproprietary Name (INN)
• Initiation of adrulipase Phase 2b pilot study with new formulation anticipated in 2H 2022

BOCA RATON, Fla., Jan. 13, 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, today provided an update on its adrulipase (FW-EPI) clinical program and advances involving adrulipase. Adrulipase is a recombinant lipase enzyme derived from the Yarrowia lipolytica yeast that First Wave BioPharma is developing for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis.

First Wave BioPharma has filed two new provisional patent applications pertaining to adrulipase with the U.S. Patent and Trademark Office (USPTO). The first application is directed to new lipase dosage forms, methods of treatment and methods of manufacturing. The Company anticipates using these dosage forms in a Phase 2b monotherapy trial in 2H 2022. The second, application expands the potential indications for adrulipase to new patient populations based on adrulipase’s potential to improve the nutritional status of individuals who may benefit from additional absorption of nutrients. Any resultant patent claiming priority to these two provisional patent filings will have an estimated term to 2042.

“This is an important step in our efforts to strengthen and expand our adrulipase intellectual property portfolio as we advance the FW-EPI clinical development program,” said James Sapirstein, President and CEO of First Wave BioPharma. “Data from the Combination Trial study and other completed clinical trials in chronic pancreatitis and cystic fibrosis patients have provided insights to potentially inform and expand the use case for adrulipase.”

In separate news, First Wave BioPharma has received formal approval from the World Health Organization (WHO) for the use of “adrulipase alfa” as the International Nonproprietary Name (INN) for the drug (formerly MS1819).

“The WHO’s approval of adrulipase alfa as the International Nonproprietary Name affirms that this drug technology is unique in design and nature, and, given the advanced stage of clinical development in the FW-EPI program, should be clearly distinguished from other pharmaceutical products,” stated Mr. Sapirstein. “An INN, also referred to as a generic name, facilitates the identification of pharmaceutical substances or active pharmaceutical ingredients and is an essential component to a drug’s product label. The assignment of adrulipase alpha to the FW-EPI clinical program provides an additional point of differentiation as we continue the drug’s development as a potential treatment for EPI that could improve upon the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT).”

First Wave BioPharma is pursuing parallel monotherapy and combination therapy clinical pathways with adrulipase. The Company reported topline results in 2021 from two Phase 2 clinical trials. The new oral formulation of adrulipase, now in development, is planned to be administered with food as a capsule that dissolves in the stomach and disperses acid-resistant micro-granules that thoroughly mix with food during the digestion process. The resultant mixture then passes to the small intestine where the lipase enzyme breaks up fat molecules so that they can be absorbed. The Company expects to complete the formulation work in the first half of 2022 and to initiate a Phase 2b monotherapy trial during the second half of 2022.

About Adrulipase
Adrulipase is a recombinant lipase enzyme that is being developed by First Wave BioPharma for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. The drug is derived from the Yarrowia lipolytica yeast and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed. It is a targeted, non-systemic biologic drug that is administered as an oral capsule medication. Unlike the current standard of care, adrulipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in maldigestion and malabsorption. The deficiency in this enzyme can be responsible for symptoms which include greasy diarrhea, fecal urge, abdominal pain, 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. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About First Wave BioPharma
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 – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. First Wave BioPharma’s niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV, for COVID-19 gastrointestinal infections and FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis. Three additional indications of niclosamide, include FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease). The Company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. 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; 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, 2020 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@azurrx.com

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett / David Schemelia
(212) 375-2665 / (609) 468-9325
jbennett@tiberend.com / dschemelia@tiberend.com