1. CRB-913 showed safety and tolerability in Phase 1 trials. 2. Participants experienced a placebo-adjusted mean weight loss of 2.9%. 3. A Phase 1b study, CANYON-1, is set for summer 2026 completion. 4. CRB-913 may serve as a unique obesity treatment with few side effects. 5. CEO expresses confidence in CRB-913’s potential as a weight loss therapy.
FAQ
Why Bullish?
The positive Phase 1a data and upcoming Phase 1b study can boost investor confidence, similar to historical trends with effective drug announcements.
How important is it?
The safety and efficacy data for CRB-913 directly influence CRBP’s market potential and investor outlook, which is crucial for a clinical-stage company.
Why Long Term?
The completion of Phase 1b in 2026 will provide crucial insights affecting CRBP's future valuation.
Corbus Pharmaceuticals Reports Positive Results from Phase 1a Study of CRB-913
December 11, 2025 | Source: GlobeNewsWire
Introduction to CRB-913
Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company concentrating on oncology and obesity, has announced promising results from its Phase 1a clinical trial of CRB-913, an oral CB1 inverse agonist aimed at managing chronic obesity. The study demonstrated a favorable safety profile and emerging evidence of weight loss, marking a significant advancement in obesity treatment.
Study Overview and Design
The completed Phase 1a study comprised two parts: single ascending dose (SAD) and multiple ascending dose (MAD) components. Conducted in the U.S., this double-blind, placebo-controlled trial evaluated the safety, tolerability, and pharmacokinetics of CRB-913 across various dosing regimens.
- Participants: 64 in SAD (8 cohorts) and 48 in MAD (4 cohorts).
- Maximum dosage: Up to 600 mg/day in SAD.
- Mean BMI of participants: 28 (healthy) and 36 (obese).
Safety and Tolerability Findings
Results indicated that CRB-913 was safe and well-tolerated at all doses. No serious treatment-emergent adverse events occurred, and gastrointestinal issues were minimal, with only one case of mild diarrhea reported.
Daily neuropsychiatric assessments using tools such as the Columbia-Suicide Severity Rating Scale (CSSRS) confirmed that all participants exhibited stable mental health with no signs of suicidality, depression, or insomnia.
- No neuropsychiatric adverse events in non-obese participants.
- Mild anxiety and irritability observed in the obese cohort at high doses, fully resolving without intervention.
Efficacy Results: Weight Loss Outcomes
In the MAD cohort specifically for obesity at a 150 mg dose, participants experienced a significant placebo-adjusted mean weight loss of 2.9% by Day 14, with all CRB-913-treated participants (n=9) losing weight compared to none in the placebo group (n=3).
This initial weight loss ranged from 1.3% to 4.3%, with some participants noting a decrease in food-related thoughts and cravings.
Future Directions: CANYON-1 Trial
Following these results, Corbus is set to initiate a Phase 1b randomized dose-ranging study, called "CANYON-1," which aims to further investigate CRB-913's efficacy and safety in a larger obese population. The study will be conducted over 12 weeks in 240 non-diabetic participants across multiple clinical sites in the U.S., with results anticipated by summer 2026.
Conference Call Announcements
Corbus will host a conference call and live webcast at 8:00 am ET today to discuss the Phase 1a study findings in detail. Experts, including Dr. Sarah Barenbaum and Dr. Daniel Lee, will provide insights during the event.
About Corbus Pharmaceuticals
Corbus Pharmaceuticals Holdings, Inc. specializes in clinical-stage oncology and obesity therapies, including a diverse drug portfolio targeting complex health conditions. The company's lead product, CRB-913, shows promise as a novel treatment alternative for obesity with an innovative mechanism of action.