BOCA RATON, Fla., April 27, 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 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).
About First Wave BioPharma, Inc.
First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. First Wave BioPharma’s niclosamide portfolio is led by two clinical programs in Phase 2 clinical trials: FW-COV for COVID-19 gastrointestinal infections and FW-UP for ulcerative proctitis (UP) and ulcerative proctosigmoiditis. Three additional indications of niclosamide, include FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients, FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease). The Company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com.
Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition and its announcement on the Company’s business, operating results and financial prospects; the integration of the First Wave Bio, Inc. business with the Company’s own business; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@firstwavebio.com
Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett / David Schemelia / Rosalyn Christian
(212) 375-2665 / (609) 468-9325 / (862) 353-9266
jbennett@tiberend.com / dschemelia@tiberend.com / rchristian@tiberend.com
