First Wave BioPharma Announces First Patient Screened for Phase 2 SPAN Adrulipase Trial in Cystic Fibrosis

Rhea-AI Summary

First Wave BioPharma (NASDAQ:FWBI) has initiated patient screening for its Phase 2 SPAN clinical trial targeting exocrine pancreatic insufficiency (EPI) in cystic fibrosis patients. Dosing is expected to start in mid-February, with topline results anticipated by mid-2023. The study will evaluate the safety, tolerability, and efficacy of a new enteric microgranule formulation of adrulipase, a recombinant lipase enzyme. The trial aims to enroll 12 patients and focuses on improving daily symptom management for chronic pancreatitis and cystic fibrosis patients. Previous therapies have been animal-derived, highlighting the significance of this non-animal alternative.

Positive

• Patient screening for the Phase 2 SPAN trial has begun ahead of schedule.
• Dosing expected to commence by mid-February.
• Topline results anticipated by mid-2023.
• The trial aims to provide a non-animal derived therapy for EPI patients.

Negative

• None.

Patient dosing expected to begin in mid-February with topline data anticipated by mid-2023

BOCA RATON, Fla., Feb. 02, 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 the first patient was screened for the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Patient dosing is expected to commence by mid-February with topline results from the study to be available by mid-2023.

“We are very pleased that patient screening has begun so soon after initiating the Phase 2 clinical trial,” said James Sapirstein, President and CEO of First Wave BioPharma. “This urgency speaks to the collective focus of First Wave’s clinical development team, the investigators and trial sites, and our CRO partner to conduct a successful Phase 2 clinical trial. Ultimately, our goal is to provide CF and chronic pancreatitis (CP) patients with a recombinant, non-porcine-derived therapeutic option that better addresses the numerous, life-altering symptoms they experience on a daily basis as a result of EPI.”

The Phase 2 multi-center clinical trial is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Three clinical trial sites in the U.S. will be participating in the trial.

“Exocrine pancreatic insufficiency is a debilitating condition that is challenging to manage for individuals with cystic fibrosis with currently available porcine-derived therapies,” said Dr. Steven Boas, founder of the Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago. “We believe that there is great potential for a non-animal derived therapy with a lower daily pill burden that could improve the nutritional health of patients and their quality of life. My investigative team and I welcome the opportunity to participate in the Phase 2 clinical trial and to test the efficacy of the new formulation of adrulipase in the clinic.”

Phase 2 SPAN Trial Design
The Phase 2 SPAN trial is designed to investigate the safety, tolerability and efficacy of a new enteric microgranule formulation of adrulipase. The SPAN trial is an open-label study that will be conducted at three sites in the U.S. A total of 12 cystic fibrosis patients, 18 years or older are expected to be enrolled. The trial design employs a dose titration strategy. Patients will be screened at baseline to ensure that they have a coefficient of fat absorption (CFA) of at least 80%. Eligible patients will then be switched from their commercial enzyme product to adrulipase. Each patient will be started on a low dose of adrulipase. If the patient is not clinically controlled, the patient will be switched to a medium dose, and if not controlled on this dose, the patient will be advanced to a high dose. The titrations will be carried out over a three-week period, after which a CFA will be obtained. End-of-study CFAs will be compared to the baseline CFAs in a descriptive fashion. A post-treatment safety visit will be conducted one week after completing the treatment period.

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 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; whether the contemplated offering will be successful and whether the Company will be able to regain and maintain compliance with Nasdaq’s continued listing criteria; 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
info@firstwavebio.com

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

Bill Borden
(732) 910-1620
bborden@tiberend.com

FAQ

What is the purpose of the Phase 2 SPAN clinical trial by FWBI?

The Phase 2 SPAN clinical trial aims to investigate the safety, tolerability, and efficacy of a new enteric microgranule formulation of adrulipase for treating exocrine pancreatic insufficiency in cystic fibrosis patients.

When is patient dosing expected to begin in the FWBI trial?

Patient dosing for the FWBI trial is expected to commence by mid-February 2023.

What are the anticipated topline results release dates for the FWBI trial?

The topline results from the FWBI trial are anticipated to be available by mid-2023.

How many patients will be enrolled in the FWBI trial?

The FWBI trial is expected to enroll 12 patients.

What are the primary endpoints of the FWBI Phase 2 trial?

The primary efficacy endpoint of the FWBI Phase 2 trial is the coefficient of fat absorption (CFA), along with secondary endpoints including stool weight and signs of malabsorption.