Corbus Pharmaceuticals Holdings Inc. announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist for obesity. This follows a successful safety and pharmacokinetics (PK) data analysis from the single ascending dose (SAD) study, which reported no treatment-related neuropsychiatric events to date. The absence of such events is a critical validation of CRB-913's peripherally restricted design.
The MAD portion of the Phase 1 trial is designed to test once-daily dosing of CRB-913 for 7 days in healthy volunteers. This phase will continue to focus on evaluating the safety, tolerability, and pharmacokinetics of increasing doses. Pre-clinical models have shown CRB-913 to be 15-fold less brain penetrant than monlunabant and to have a 50 times lower brain-to-plasma ratio than rimonabant, reinforcing its differentiated safety profile.
The MAD study is on track for completion in the third quarter of 2025. This progression in the clinical development of CRB-913 is a significant milestone, as it aims to unlock the clinically validated weight-loss mechanism of CB1 inverse agonism without the central nervous system side effects that plagued earlier compounds. The positive early safety data supports the continued advancement of this promising obesity candidate.
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