Data suggest technology provides improved delayed-release profile that ensures adrulipase is delivered to targeted areas of the GI tract
First Wave BioPharma expects to initiate Phase 2 trial investigating "optimized adrulipase" prior to year-end 2022
BOCA RATON, Fla., Sept. 07, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., 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 the selection of an enhanced enteric microgranule drug delivery formulation for the ongoing development of its adrulipase clinical program (FW-EPI). First Wave BioPharma now plans to submit an Investigational New Drug (IND) amendment to the U.S. Food & Drug Administration (FDA) for a Phase 2 "proof-of-concept" clinical study investigating the optimized version of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). First Wave BioPharma expects to initiate the Phase 2 trial prior to year-end 2022 following acceptance of the IND.
In vitro data suggest the new formulation provides a delayed-release profile that should ensure adrulipase is protected in the stomach and delivered to the targeted areas of the GI tract, allowing for adrulipase to mix with food in the duodenum where it can then provide its therapeutic effect. This improvement is expected to result in consistent coefficient of fat absorption (CFA) values greater than 80%. CFA greater than 80% is the recognized threshold for achieving therapeutic benefit in patients with EPI associated with CF and CP.
Additionally, the research indicates the enhanced formulation has the potential to significantly decrease the number of pills a patient would need to take to achieve the desired therapeutic effect. The pill burden associated with pancreatic enzyme replacement therapy (PERT) can be as high as 40 capsules per day, creating a substantial challenge for EPI patients. The ability to reduce the number of pills while maintaining effectiveness is considered a key differentiator for patients. Further, First Wave BioPharma has identified manufacturing improvements that have the potential to lower the cost of goods by significantly increasing production yields.
"The selection of the enteric microgranule drug delivery technology follows extensive research by First Wave BioPharma and our drug delivery formulation partner, Pace® Life Sciences, into the development and manufacturing of the optimized adrulipase formulation," said James Sapirstein, President and CEO of First Wave BioPharma. "We are pleased to report that by every measure the new adrulipase formulation outperformed prior versions of the drug, and we look forward to evaluating this potential in a proof-of-concept Phase 2 clinical trial, which we expect to initiate before year-end. Our hope is that with this improved formulation we are an important step closer to improving the lives of patients with exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis."
Research involving the optimized adrulipase formulation will be the subject of a poster presentation at AAPS 2022 PharmSci 360 being held in Boston on October 16-19, 2022.("Formulation Development of Enterically Protected Spray Dried Dispersions of Adrulipase"). Additionally, First Wave BioPharma previously published a white paper detailing the development of the microgranule formulation for adrulipase. The white paper 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 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 from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. 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. A subsidiary of Pace® Science and Technology Company, Pace® Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and regulatory and manufacturing support service centers across the United States. 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; 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
info@firstwavebio.com
Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia
(609) 468-9325
dschemelia@tiberend.com
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