First Wave BioPharma’s CEO James Sapirstein issues letter to stockholders

First Wave BioPharma 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 letter provided an update on the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency, or EPI, in patients with cystic fibrosis, or CF. The letter stated, “If successful, we believe adrulipase has the potential to supplant porcine PERT as the standard of care for EPI associated with CF in an estimated $2.2B global market. Given this, our plan is to proceed to a Phase 3 registration trial following the expected topline data readout in July. The first step in this process would be scheduling an End of Phase 2 meeting with the FDA, which we would aim to secure in the Q4 of 2023.” The letter also reported, “On June 22, 2023, First Wave held its 2023 Annual Meeting of Stockholders (the “Annual Meeting”) during which stockholders had the opportunity to vote on five proposals. We are pleased to report that all proposals passed, including the re-election of five members to our board of directors. Maintaining continuity of leadership during this important phase of growth for the Company is critically important, and we are grateful for the ongoing support of our stockholders.”