First Wave BioPharma Presents Research Demonstrating Benefits of Improved Adrulipase Drug Delivery Formulation at AAPS 2022 PharmSci 360

Rhea-AI Summary

First Wave BioPharma (NASDAQ:FWBI) announces its poster presentation detailing a new microgranule formulation of adrulipase, showcasing a targeted delayed release profile effective in both acidic and intestinal environments. The findings, presented at AAPS 2022 PharmSci 360 on October 19, indicate that this formulation may enhance drug delivery for treating exocrine pancreatic insufficiency (EPI) linked to cystic fibrosis and chronic pancreatitis. The Company aims to initiate a Phase 2 clinical trial by year-end 2022. They reported significant advancements in manufacturing yields and reductions in production costs.

Positive

• New microgranule formulation of adrulipase shows improved drug delivery.
• Formulation has approximately double the drug load compared to previous versions.
• Research indicates potential for effective drug release and gastrointestinal protection.
• Plans to initiate Phase 2 clinical trial for optimized formulation by year-end 2022.
• Improvements in manufacturing yields and cost reductions reported.

Negative

• None.

Poster presentation indicates new microgranule formulation elicited desired delayed release profile, offering protection at acidic pH and rapid release under intestinal conditions

BOCA RATON, Fla., Oct. 10, 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 research demonstrating key advantages of its improved adrulipase drug delivery formulation will be the subject of a poster presentation at AAPS 2022 PharmSci 360 on October 19 at 9:30 a.m., EDT. First Wave is developing adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). A Phase 2 clinical trial investigating the optimized adrulipase formulation is expected to initiate before year-end 2022.

The poster (W0930-01-02), entitled, “Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase,” highlights research conducted by First Wave BioPharma and its drug delivery formulation partner, Pace^® Life Sciences, involving the development of a new drug delivery formulation for adrulipase. In vitro data suggest the formulation (SDD04), which was compared against eight other formulations of adrulipase, has the potential to offer the best protection against the acidic pH in the stomach followed by rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit. Notably, the SDD04 formulation contained approximately two times higher drug load than previous formulations and retained activity even after 90 minutes under dissolution conditions.

“We are very pleased that research into the development of a microgranule delivery formulation for adrulipase will be highlighted at the AAPS 2022 PharmSci 360 conference,” said James Sapirstein, President and CEO of First Wave BioPharma. “As the data indicate, we have been able to identify a drug delivery formulation of adrulipase that should consistently deliver the drug to the precise location in the gastrointestinal tract where it can produce its therapeutic effect. In addition, we have made significant strides in increasing our manufacturing yields and decreasing our cost of goods. We are now in the process of completing the Investigational New Drug (IND) application for a proposed Phase 2 clinical trial of this optimized formulation, which we expect to initiate prior to year-end.”

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.

About Pace^® Life Sciences, Inc.
Pace^® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Pace^® Life Sciences operates from a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers across the United States. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasizes our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. Pace^® Life Sciences is a part of Pace^®, a Science and Technology Company. More at pacelifesciences.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

 

FAQ

What is the significance of the new adrulipase formulation presented by First Wave BioPharma?

The new adrulipase formulation offers improved drug delivery, with a delayed release profile effective in acidic conditions and rapid release in the intestine, which could enhance treatment outcomes for EPI.

When is the Phase 2 clinical trial for the optimized adrulipase formulation expected to begin?

The Phase 2 clinical trial for the optimized adrulipase formulation is expected to start before the end of 2022.

What are the key advantages of the new adrulipase formulation mentioned in the press release?

The key advantages include a higher drug load, better protection against stomach acidity, and rapid drug release in the small intestine.

Where will the new adrulipase formulation research be presented?

The research on the new adrulipase formulation will be presented at the AAPS 2022 PharmSci 360 conference.

What is exocrine pancreatic insufficiency (EPI) and its relevance to the adrulipase formulation?

EPI is a condition causing difficulty in digesting food due to enzyme deficiency, and the adrulipase formulation aims to provide effective treatment for this condition in patients with cystic fibrosis and chronic pancreatitis.