Trial Enrollment Completed for Investigational Therapy of Exocrine Pancreatic Insufficiency
First Wave BioPharma, Inc. (NASDAQ: FWBI), a clinical-stage biopharmaceutical company focusing on the development of targeted, non-systemic therapies for gastrointestinal diseases, announced today that it has reached the enrollment target for its ongoing Phase 2 SPAN clinical trial. The study is designed to explore the efficacy and safety of an enhanced enteric microgranule delivery formulation of adrulipase in treating exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
Phase 2 SPAN Clinical Trial Underway
Two-thirds of the patients have completed the study, with the remainder receiving their dosages. The Phase 2 multi-center clinical trial (NCT05719311) aims to assess the safety, tolerability, and effectiveness of an enteric microgranule delivery formulation for adrulipase in a dose-escalation study involving an estimated twelve patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), along with secondary endpoints such as stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption (CNA). Topline data from the study is projected for July 2023.
James Sapirstein, CEO of First Wave BioPharma, expressed satisfaction with the enrollment achievement. He added, “We remain on track to report topline data in July 2023.”
Exploring Adrulipase: A Potential Solution for EPI
Adrulipase is a recombinant lipase enzyme designed to break up fat molecules in the digestive tract of EPI patients, aiding their absorption as nutrients. It is administered as an oral, non-systemic biologic capsule for the treatment of EPI associated with cystic fibrosis and chronic pancreatitis. EPI is a disorder caused by a deficiency in the exocrine pancreatic enzymes, resulting in improper digestion of food. Symptoms of this deficiency can include greasy diarrhea, fecal urge, and weight loss.
According to the Cystic Fibrosis Foundation, there are approximately 40,000 patients in the U.S. with EPI caused by cystic fibrosis, and around 95,000 patients in the U.S. with EPI caused by chronic pancreatitis as per the National Pancreas Foundation. This marks a significant milestone in the development of targeted therapies for gastrointestinal diseases.
First Wave BioPharma’s Commitment to Innovation
This achievement signifies First Wave BioPharma’s dedication to the development of targeted therapies for GI diseases. The company’s focus on research and development and commitment to patients are evident in their Phase 2 SPAN clinical trial progress. First Wave BioPharma is on a mission to transform the therapeutic landscape for patients with gastrointestinal diseases by advancing the development of innovative treatments like adrulipase for EPI.
With the clinical study making significant strides, all eyes are set on July 2023, when First Wave BioPharma is scheduled to report topline data. This could open a new chapter in the management and treatment of gastrointestinal diseases, positively impacting the lives of thousands of patients.
First Wave BioPharma Raises $2.4 Million through Private Placement of Warrants
First Wave BioPharma announced today that it has finalized agreements with specific holders of its existing warrants for 1,681,667 shares of its common stock to exercise their warrants at a reduced price of $1.15 per share. This transaction, structured as an at-market transaction under Nasdaq rules, leads to the issuance of new warrants and will generate an estimated gross proceeds of $2.4 million, excluding financial advisory fees.
Roth Capital Partners has been appointed as the company’s financial advisor for this transaction. The shares of common stock that can be obtained through the exercise of the warrants are registered according to a registration statement on Form S-1 (File No. 333-267423), declared by the SEC on October 6, 2022, and a registration statement on Form S-3 (File No. 333-268660), declared effective by the SEC on December 8, 2022.
In exchange for immediate cash exercise of the warrants and the payment of $0.125 per share underlying the new warrants, holders will receive new warrants to purchase common stock in a private placement according to Section 4(a)(2) of the Securities Act of 1933 (the “1933 Act”). The new warrants will be exercisable for up to 3,363,354 shares of common stock at an exercise price of $1.15 per share with a term of five years.
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