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First Wave BioPharma Chairman and CEO Issues Letter to StockholdersBOCA RATON, Fla., Sept. 19, 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, today announced that James Sapirstein, Chairman, President and CEO First Wave BioPharma, has issued a Letter to Stockholders to provide 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 are excited by the news announced last week concerning adrulipase, our product candidate for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). As we announced, after extensive research by First Wave BioPharma and our drug delivery formulation partner, we believe we have identified an enhanced enteric microgranule drug delivery formulation of adrulipase for use in the continued development of our clinical program (FW-EPI). We intend to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) for a Phase 2 “proof-of-concept” clinical study investigating the improved formulation of adrulipase as a potential treatment for EPI. We anticipate that this trial will commence prior to year-end 2022, subject to FDA’s acceptance of the IND. We believe the new formulation will allow us to reignite our adrulipase development program. For those new to First Wave BioPharma, adrulipase is our most clinically advanced asset and we believe it offers the potential to be a best-in-class treatment for EPI associated with CF and CP. The cumulative data generated in our earlier clinical trials of adrulipase demonstrated an excellent safety profile and a mechanism of action that we believe should enable a therapeutic benefit. However, as previously reported, the prior formulation resulted in an inconsistent dispersal of adrulipase in the gastrointestinal tract which resulted in it not achieving its efficacy endpoints. In our in vitro testing, the new enteric microgranule drug delivery formulation of adrulipase outperformed prior versions of the drug while enabling us to make significant improvements in manufacturing yields and lowering our costs. The in vitro data suggest the new formulation has a delayed-release profile that should protect adrulipase in the stomach and enable it to be delivered to the targeted areas of the GI tract where it can mix with food in the duodenum to provide its therapeutic effect. 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. Additionally, our research indicates that 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 fo EPI patients. We believe that a reduction in the number of pills required to maintain effectiveness will be a key differentiator for patients. Moreover, we have identified manufacturing improvements that we believe have the potential to lower the cost of goods by significantly increasing production yields. We are excited to present the research relating to this improved adrulipase formulation at AAPS 2022 PharmSci 360 in Boston next month. Given these important advances with adrulipase, we have made the strategic decision to direct our near-term resources towards the filing of the IND and the Phase 2 clinical trial of the new adrulipase formulation. As a result, we will be devoting fewer resources to our niclosamide programs following the mixed results from the COVID-19 trial (FW-COV) and inconclusive data from a small Phase 2 trial of niclosamide in ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). We have also taken significant steps to improve our balance sheet, including settling the lawsuit filed against us by the former stockholders of First Wave Bio, Inc. on terms that included a significant restructuring of our obligations to them. The restructuring resulted in the elimination of approximately $10 million of fixed liabilities from our balance sheet. In compliance with our plan to regain and maintain compliance with Nasdaq’s continued listing requirements, we effected a reverse stock split of our common stock in late August and have raised a significant amount of new capital since June 30, 2022, primarily through our at-the-market sales program, which is now complete. As part of our Nasdaq compliance plan, we hope to raise additional capital, subject to market conditions, to meet Nasdaq’s continuing listing standards and to support our business. As many of our stockholders are painfully aware, the first nine months of 2022 have been a difficult time for biotechnology stocks of all sizes. Despite the challenges we have faced, the Company has made significant strides in its clinical development efforts and substantially improved its balance sheet and capital position. We are excited for the future. In closing, we remain committed to bring relief to patients living with the often painful, dangerous and discomforting symptoms tied with GI disease, to protect their health and to restore quality of life. Sincerely, About First Wave BioPharma, Inc. Forward-Looking Statement For more information: Media contact: Dave Schemelia |