Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) shares rose 12% on Monday after the company reported topline results from its CANYON-1 Phase 1b clinical trial evaluating CRB-913 as a treatment for obesity.
The study showed statistically significant mean weight loss compared with placebo across all three doses tested, with the highest 60 mg dose producing mean weight loss of 5.0% at week 12. Corbus said no weight-loss plateau was observed at that dose.
CRB-913 is an oral, non-incretin obesity drug designed as a peripherally restricted CB1 inverse agonist.
CANYON-1 Enrols 254 Participants
CANYON-1 was a 16-week, double-blind, placebo-controlled, dose-ranging trial involving 254 adults with obesity and without diabetes across 15 sites in the United States.
Participants received CRB-913 at doses of 20 mg, 40 mg or 60 mg orally once daily, or placebo.
At week 12, mean weight loss was 2.8% for the 20 mg group, 3.3% for the 40 mg group and 5.0% for the 60 mg group. All three doses produced statistically significant weight loss compared with placebo.
Among participants who completed the study and received the 60 mg dose, all lost weight, while 44.4% recorded weight loss of at least 5% from baseline.
Corbus Reports Safety and Tolerability Findings
Corbus said CRB-913 was generally well tolerated during the study. Discontinuations due to adverse events ranged from 3.1% to 13.1% across the treatment groups.
Psychiatric adverse events were described by the company as infrequent, mild to moderate and transient. No serious or severe psychiatric adverse events or cases of suicidality were reported, while one case of transient depressive symptoms occurred.
Gastrointestinal adverse events were mild or moderate across all doses, with no serious or severe cases reported.
Corbus said the treatment discontinuation rate was in line with approved oral GLP-1 therapies and said the emerging gastrointestinal profile appeared more tolerable than the oral GLP-1 class. These comparisons reflect the company’s assessment of the trial data.
Phase 2 Study Planned for 2027
Corbus plans to discuss the clinical development programme for CRB-913 with the US Food and Drug Administration.
The company expects to begin a Phase 2 monotherapy trial in the first half of 2027 following the Phase 1b results.
Corbus Pharmaceuticals Holdings stock price
