First Wave BioPharma Files Investigational New Drug Application for Enhanced Microgranule Delivery Formulation of Adrulipase

Upon IND clearance, Phase 2 clinical trial investigating adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis is expected to initiate in early 2023 with topline clinical data anticipated in the first half of 2023

BOCA RATON, FL, USA I November 30, 2022 I 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 it has submitted an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (FDA) to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) in human clinical trials. Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.

“Filing the IND is an important step in enabling First Wave to initiate the planned Phase 2 trial of our new formulation for adrulipase,” said James Sapirstein, President and CEO of First Wave BioPharma. “If the FDA grants authorization in the next 30 days, we expect to start the study in early 2023 with topline data anticipated towards the end of the first half of 2023.”

“We anticipate that these near-term clinical milestones will reinforce our previous research, such as data recently presented at AAPS 2022 showing the new adrulipase formulation can deliver the drug in the intended area of the gastrointestinal tract, where it can provide the desired therapeutic effect,” Sapirstein added. “We look forward to investigating this potential in a Phase 2 clinical trial and the opportunity to one day provide therapeutic relief to patients with exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.”

In vitro data suggest the microgranule drug delivery formulation offers improved protection against the acidic pH in the stomach followed by the rapid release of adrulipase in the small intestine where the drug is expected to mix with food and deliver its therapeutic benefit. Additionally, in vitro 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 for current commercial pancreatic enzyme replacement therapy (PERT) can be as high as 40 capsules per day, creating a substantial challenge for EPI patients.

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.

SOURCE: First Wave BioPharma

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