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First Wave BioPharma Forms Clinical Steering Committee Focused on Advancing Inflammatory Bowel Disease (IBD) Product Portfolio ($FWBI)

First Wave BioPharma,Inc., (NASDAQ:FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, on Wednesday announced the formation of a clinical steering committee focused on advancing the Company’s inflammatory bowel disease (IBD) product portfolio, including FW-UP (ulcerative proctitis and ulcerative proctosigmoiditis), FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease). First Wave BioPharma is currently advancing a Phase 2 clinical trial investigating FW-UP, a topical formulation of niclosamide, for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS).

The four-member steering committee will provide management with strategic guidance and support during the execution of the FW-UP Phase 2 trial as well as the advancement of clinical programs for FW-UC and FW-CD. The committee members include Brian Feagan, M.D., Professor of Medicine, Epidemiology and Biostatistics at Western University and Senior Scientific Director, Alimentiv, Inc.; Stephen B. Hanauer, M.D., Medical Director of the Digestive Health Center at Northwestern Medicine and Clifford Joseph Barborka Professor of Medicine in the Northwestern Feinberg School of Medicine; Giovanni Monteleone, M.D., Professor and Head, Department of Gastroenterology at the University of Rome Tor Vergata; and Julian Panes, M.D., Professor of Medicine and the Chief of the Department of Gastroenterology at Hospital Clinic de Barcelona.

“Our inflammatory bowel disease product portfolio, led by FW-UP, is a significant near-term and longer-range growth driver for First Wave BioPharma and was a key factor in our decision to acquire First Wave Bio. Given this importance to the company, we are very excited to announce the formation of a clinical steering committee comprised of world-renowned experts in IBD,” stated James Sapirstein, President and CEO of First Wave BioPharma. “Each committee member brings extensive expertise as researchers and clinicians in the treatment of gastrointestinal and inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. We expect to benefit immediately from their collective experience as we accelerate our FW-UP program and look to initiate clinical trials of FW-UC and FW-CD.”

About the IBD Steering Committee

Dr. Brian Feagan is a world-renowned gastroenterologist, with expertise in inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn’s disease. He currently serves as Professor of Medicine, Epidemiology and Biostatistics at Western University and Senior Scientific Director at Alimentiv, Inc. Dr. Feagan’s research efforts focus on the design and implementation of randomized controlled trials of therapy for IBD. He has served as principal investigator on more than 140 multi-center clinical trials focused on novel IBD therapeutics.

Dr. Stephen Hanauer currently serves as Medical Director of the Digestive Health Center at Northwestern Medicine and is a Clifford Joseph Barborka Professor of Medicine in the Northwestern Feinberg School of Medicine. Dr. Hanauer is board certified in internal medicine and gastroenterology by the American Board of Internal Medicine and the American Board of Gastroenterology, respectively. He holds membership in several professional societies and is a Fellow of American Gastroenterological Association, the American College of Gastroenterology and the American College of Physicians. In connection with the American Gastroenterological Association (AGA), Dr. Hanauer served as chair for the Inflammation, Immunology, and Inflammatory Bowel Disease Section and the Clinical Practice Section and subsequently served as Councilor for Clinical Research on the AGA Governing Board. He is a prior member of the Specialty Board of the American Board of Internal Medicine. Among his many honors, Dr. Hanauer received the AGA Fiterman Foundation Joseph B. Kirsner Award in Gastroenterology in 2001 and the Janssen Award for Clinical Excellence in 2004. He has served as a Member and Chair of the U.S. Food and Drug Administration Advisory Panel for Gastrointestinal Disorders and is a member and former Chairman of the International Organization for Inflammatory Bowel Disease.

Dr. Giovanni Monteleone is a Professor and Head of the Department of Gastroenterology at the University of Rome Tor Vergata in Rome, Italy and serves as the lead investigator in First Wave BioPharma’s Phase 2 clinical trial investigating a topical formulation of niclosamide (FW-UP) as a potential treatment for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). Since joining the faculty at the University of Rome Tor Vergata in 2003, Dr. Monteleone has pursued research on the mechanisms involved in the control of mucosal immune homeostasis and inflammatory signals that sustain and amplify pathological processes in the gastrointestinal tract that has contributed to delineating novel pathways of intestinal mucosal damage and the development of anti-inflammatory compounds. Dr. Monteleone has authored 300 peer-reviewed articles, books, and book chapters, and serves as an editorial board member for several medical journals. He received his medical degree from the University Magna Graecia of Catanzaro in Italy, where he also completed an internship, a residency, and a fellowship in gastroenterology.

Dr. Julian Panes is Professor of Medicine and the Chief of the Department of Gastroenterology at Hospital Clinic de Barcelona. His research team works on the identification of new molecular targets for the treatment of inflammatory bowel diseases, the development of cell therapies and the implementation of new diagnostic tools, with a particular focus on cross-sectional imaging. Dr. Panes is an expert on performing early- to late-stage clinical trials for new IBD therapeutics. Dr. Panes was President of the European Crohn’s and Colitis Organization (ECCO) and is currently a member of the American Gastroenterology Association (AGA).

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