 BOCA RATON, Fla., Oct. 19, 2021 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, announced today that the U.S. Food and Drug Administration FDA has reviewed the Investigational New Drug IND application and provided a Study May Proceed letter for the Companys Phase 2a PASSPORT trial investigating FW-ICI-AC as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors ICIs. FW-ICI-AC is a proprietary oral immediate-release tablet formulation of niclosamide, a prescription small molecule with anti-inflammatory and anti-viral properties. 