Core Insights - Corbus Pharmaceuticals has completed the Phase 1a study of CRB-913 and initiated a Phase 1b study, with results expected in summer 2026 [1][8] Study Overview - The Phase 1a study included a double-blinded placebo-controlled design, assessing safety, tolerability, and pharmacokinetics of CRB-913 with a maximum dose of 600 mg/day [2] - The study involved 64 participants in the single ascending dose (SAD) portion and 48 participants in the multiple ascending dose (MAD) portion [2] Safety and Tolerability - No serious treatment-emergent adverse events were reported, and CRB-913 showed no gastrointestinal intolerability [3] - Neuropsychiatric assessments indicated stability with no reported cases of suicidality, depression, or insomnia [4][5] Efficacy Results - In the obese MAD cohort, participants treated with CRB-913 experienced a placebo-adjusted mean weight loss of 2.9% by Day 14, with individual weight loss ranging from 1.3% to 4.3% [6][8] - Participants reported a reduction in food-related thoughts and cravings, indicating potential efficacy in weight management [6] Future Developments - The Phase 1b CANYON-1 study will involve 240 obese, non-diabetic participants and will assess three dosing cohorts of CRB-913 [11] - The study design includes a dose titration regimen starting at 20 mg/day [11] About CRB-913 - CRB-913 is a peripherally restricted CB1 inverse agonist designed to minimize brain penetration, potentially reducing neuropsychiatric risks associated with earlier drugs in this class [12]
Corbus Pharmaceuticals Reports Results from Phase 1a Study of Oral CB1 Inverse Agonist CRB-913 for the Treatment for Obesity Demonstrating Favorable Safety Profile and Emerging Evidence of Weight Loss