First Wave BioPharma Chairman and CEO Issued Letter to Stockholders; Said We Expect to File an IND Application With the FDA to Evaluate an Enhanced Enteric Microgranule Delivery Formulation of Adrulipase as a Potential Treatment for Exocrine Pancreatic Insufficiency Associated With Cystic Fibrosis and Chronic Pancreatitis in Human Clinical Trials
Benzinga · 11/16/2022 07:08
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 James Sapirstein, Chairman, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company's clinical programs and recent events. The full text of the letter follows. A MESSAGE FROM OUR CHAIRMAN AND CHIEF EXECUTIVE OFFICER To my fellow stockholders, We expect to file an Investigational New Drug (IND) application with U.S. Food and Drug Administration (FDA) to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a potential treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) in human clinical trials. Once we receive FDA clearance of our IND, First Wave expects to initiate a Phase 2 clinical trial prior to year-end 2022 with top-line data anticipated by the end of the first half of 2023. Adrulipase is our most clinically advanced asset, and we believe our enhanced formulation offers the potential to be a best-in-class treatment for EPI associated with CF and CP. As disclosed previously, 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. Based on our in vitro testing, we expect that the new formulation of adrulipase will 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. During 2022, we have implemented significant cost-cutting measures to conserve cash to support clinical development of adrulipase. We also restructured our obligations to the former stockholders of First Wave Bio, Inc. which eliminated $10 million of fixed liabilities from our balance sheet. Pursuant to our plan to regain and maintain compliance with Nasdaq's continued listing requirements, we completed a reverse stock split of our common stock in late August and have raised a significant amount of new capital since June 30, 2022, including a $6 million stock and warrant offering in October. We intend to raise additional capital, subject to market conditions, to complete our compliance plan by the November 22, 2022 deadline and to support our business. We remain dedicated to fulfilling our mission to help alleviate the suffering of patients with gastrointestinal (GI) disease, especially those with EPI. We attended the most recent North American Cystic Fibrosis Conference (NACFC) in Philadelphia and met with clinicians, KOLs and patient advocates. In our discussions, they have expressed a strong desire for adrulipase given the many challenges presented by the current standard of care, pancreatic enzyme replacement therapy (PERT). The pill burden for current commercial PERT medications can be as high as 40 capsules per day, creating a substantial challenge for EPI patients. We believe that our adrulipase formulation will reduce the number of pills required to maintain effectiveness which will be a key differentiator for patients. I want to thank everyone again for investing in and supporting our Company. Despite the current market conditions, we remain very optimistic about the prospects for adrulipase and look forward to initiating our next Phase 2 clinical trial. Sincerely, James Sapirstein Chairman, President and CEO First Wave BioPharma, Inc.