First Wave BioPharma Announces Phase 2 Adrulipase Combination Trial Data to be Presented at the 2023 Digestive Disease Week (DDW) Conference

BOCA RATON, Fla., Feb. 21, 2023 (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 announced that an abstract entitled, “Results from an Open-Label, Phase 2 Study with Escalating Doses of Adrulipase Alfa on top of a Stable Dose of Porcine Pancreatic Enzymes (PPE) in CF Patients Not Fully Compensated with PPE as Sole Therapy,” has been accepted for a presentation at the 2023 Digestive Disease Week Conference (DDW 2023). The conference is taking place May 6-9, 2023, in Chicago.

The presentation by Michael Konstan, M.D., Vice Dean for Translational Research at Case Western Reserve University School of Medicine and a clinical expert in exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF), will share data from the Phase 2 adrulipase Combination Therapy Trial which evaluated the safety and efficacy of adrulipase in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe EPI in patients with CF.

“The research presented at DDW 2023 is intended to highlight the potential benefits that adrulipase may offer in the treatment of EPI above and beyond PERT, the current standard of care,” stated James Sapirstein, President and CEO of First Wave BioPharma. “For patients with severe EPI, it can be difficult to gain adequate control of their symptoms despite receiving doses of PERT at the maximum level. Adding a synthetic lipase like adrulipase to PERT has demonstrated the potential to improve fat absorption and overall nutrition of CF patients. Given this, we believe adrulipase has the potential to be a best-in-class treatment for EPI associated with CF and CP, both as a monotherapy and in combination with PERT.”

Details on the time and location of the presentation are as follows:

First Wave BioPharma is currently advancing the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase as a monotherapy for the treatment of exocrine pancreatic insufficiency (EPI) in patients CF. Patient dosing is expected to commence in February with topline results from the study to be available by mid-2023.

Phase 2 Combination Therapy Trial

The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs^(1,2).  Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function ^(3,4).

The Phase 2 combination clinical trial was a multi-center study designed to investigate the safety, tolerability and efficacy of escalating doses of adrulipase, in conjunction with a stable dose of PERT, in order to increase the patient’s coefficient of fat absorption (CFA) levels and relieve abdominal symptoms. The study enrolled 20 patients, 12 years of age or older, with severe EPI who were treated escalating doses of adrulipase (700mg, 1200mg, and 2240mg) once daily for 15 days per dosing level, in addition to their standard PERT dose. Trial eligibility required a CFA of less than 80%. The primary efficacy endpoint of the trial was improvement in CFA; secondary endpoints of the study were improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.

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 Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023. The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at .

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 .

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 maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; 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

 

Media contact:



David Schemelia

(609) 468-9325

Bill Borden

(732) 910-1620

(1) Freedman, S.D., Am. J. Manag. Care, 2017; 23: S2220-S228

(2) Littlewood, J. et al, 2006, Pediatric Pulmonology, 2006, 41:35-49

(3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Care; 17(6):515-520

(4) Vandenbranden, S.L. et al, 2012, Pediatric Pulmonology, 2012; 47(2): 135-143