Benzinga | Oct 21, 2021 12:11PM EDT

Fist Wave BioPharma Reports Formation Of Steering Committee For Phase 2a PASSPORT Trial To Evaluate FW-ICI-AC In Cancer Patients With Immune Checkpoint Inhibitor-Associated Colitis

Committee members include globally renowned experts in medical oncology, immune checkpoint inhibitor therapeutics, gastrointestinal (GI) diseases and cancer immunotherapy-related GI complications

BOCA RATON, Fla., Oct. 21, 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, today announced the initial members of the steering committee for PASSPORT, the Company's Phase 2a clinical 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.

The four-member steering committee will provide management with strategic guidance and support during the initiation and execution of the PASSPORT trial. The committee members include Mike Dougan, Ph.D., M.D., Director of the Immunotherapy Mucosal Toxicities Program at Massachusetts General Hospital; Yinghong ("Mimi") Wang, Ph.D., M.D., Director of Inflammatory Bowel Disorder and Director of Fecal Microbiota Transplantation, Department of Gastroenterology, Hepatology and Nutrition at University of Texas MD Anderson Cancer Center; Aiwa Ruth He, Ph.D., M.D., Assistant Professor, Division of Hematology and Oncology at Georgetown University Hospital; and David Faleck, M.D., Assistant Professor of Medicine at Weill Medical College and an attending physician in the Gastroenterology, Hepatology and Nutrition Service at Memorial Sloan Kettering Cancer Center (MSK).

"To have assembled such a prestigious group of medical experts from some of the nation's most renowned cancer centers is an exciting development as we advance the exploration of FW-ICI-AC as a potential treatment for immune checkpoint inhibitor-associated colitis," stated James Sapirstein, President and CEO of First Wave BioPharma. "Each committee member brings extensive expertise as researchers and clinicians in the treatment of the GI-related complications that often occur in cancer patients undergoing treatment with immunotherapies. We believe there is significant potential for FW-ICI-AC to be a difference maker that can help address the needs of millions of cancer patients who, due to GI-related complications, might otherwise be forced to cease immunotherapy treatment."

James Pennington, M.D., Chief Medical Officer for First Wave BioPharma, stated, "As many as 30 percent of cancer patients treated with checkpoint inhibitors develop diarrhea that can progress to colitis, a condition that can be debilitating and, at times, life-threatening due to the compromised heath of the patient. We believe niclosamide has the potential to be the first drug specifically for ICI-AC and, thus, could become a critical component to the treatment regimen for cancer patients receiving immune checkpoint inhibitors."