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Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA Berobenatide
Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA
About this update from Pfizer, Inc.
Pfizer Inc. (NYSE: PFE) today presented detailed results from multiple Phase 2b studies of berobenatide (PF’3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide, during a late-breaking expert symposium at the 86th Scientific Sessions of the American Diabetes Association (ADA). The objectives for the Phase 2 studies were to identify the right doses for Phase 3 and to test escalation schemes. Across both weekly and monthly dosing in participants with obesity or overweight, with and without type 2 diabetes, the data from the Phase 2b VESPER-1, 2 and 3 studies: provide proof of concept for berobenatide as a potential first-in-class monthly GLP-1 RA peptide that can deliver competitive weight loss; show favorable tolerability for berobenatide, including low gastrointestinal (GI) adverse events and discontinuations despite rapid dose escalation and no allowed step-down; and highlight the potential for monthly delivery in a patient-friendly presentation with a very low 0.5 mL injection volume that provides convenience and scalability advantages. The first clinical experience with the top weekly dose for berobenatide is being presented today for the first time. Results from a 32-week exploratory extension (Part B) of the Phase 2b VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9%* with no plateau observed at 32 weeks on berobenatide (Week 60 of the overall study), in participants who escalated from placebo to 2.4 mg weekly berobenatide. VESPER-1 is evaluating once-weekly berobenatide in adults with obesity or overweight, including Part B to assess the durability of weight loss and the impact of transitioning from once-weekly to less frequent dosing regimens, including once-monthly. "In Phase 2b studies, berobenatide delivered continuous, uninterrupted weight loss at all doses selected for Phase 3, while preserving a tolerable profile as people transitioned from a weekly to a monthly maintenance dose,” said Jim List, MD, PhD, Chief Internal Medicine Officer, Pfizer. “These data highlight the potential for berobenatide to be the first approved monthly GLP-1 RA peptide and support our extensive Phase 3 program that includes 10 studies for chronic weight management and obesity-related comorbidities. With berobenatide as a potential foundational metabolic medicine, both as a single agent and as a combinat...