Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) has finished its single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) Phase 1a study of the orally administered CB1 inverse agonist CRB‑913 and has begun a 12‑week, 240‑patient Phase 1b dose‑range‑finding trial, CANYON‑1, slated to conclude in summer 2026.
The Phase 1a study enrolled 112 participants across eight SAD cohorts and four MAD cohorts, with daily doses ranging from 25 mg to 600 mg. No serious treatment‑emergent adverse events were reported, and the drug showed a favorable safety profile, including the absence of neuropsychiatric events in both healthy and obese subjects. In the obese MAD cohort at 150 mg/day, all nine treated participants lost weight, achieving a mean placebo‑adjusted weight loss of 2.9 % by Day 14, with individual losses between 1.3 % and 4.3 %.
The Phase 1b study will evaluate three dose levels—20 mg, 40 mg, and 60 mg—in obese, non‑diabetic adults. The trial design incorporates a dose‑titration schedule and will assess safety, tolerability, pharmacokinetics, and preliminary efficacy over 12 weeks, with enrollment of 240 participants and an expected completion in summer 2026.
CRB‑913’s safety profile is a key differentiator. The drug is engineered as a highly peripherally restricted CB1 inverse agonist, limiting brain penetration and thereby avoiding the neuropsychiatric side effects that led to the withdrawal of earlier CB1 agents such as rimonabant. The absence of serious adverse events and the resolution of mild anxiety and irritability in the 150 mg/day cohort reinforce the safety advantage of this design.
The early efficacy signal is encouraging. A 2.9 % mean weight loss in the 150 mg/day cohort, achieved within 14 days, suggests that CRB‑913 can produce clinically meaningful weight reduction. In a market dominated by GLP‑1 agonists like semaglutide and tirzepatide, a small‑molecule oral therapy with a favorable safety profile could capture a substantial share of the obesity treatment landscape, either as monotherapy or in combination with existing agents.
Corbus’s financial position supports continued development. The company has maintained a strong cash balance and recently completed equity offerings to fund its pipeline, which also includes oncology candidates CRB‑701 and CRB‑601. This financial backing provides the runway needed to advance CRB‑913 through Phase 2 and beyond without immediate revenue generation.
Chief Executive Officer Yuval Cohen emphasized the significance of the results: “The data confirm that CRB‑913’s peripherally restricted design delivers a class‑leading safety profile while generating early weight‑loss signals. We are confident that the Phase 1b study will further validate these findings and bring us closer to a safe, effective obesity therapy.”
Investor sentiment has been positive, reflecting confidence in the safety and early efficacy data and the company’s strong financial footing. The announcement is expected to reinforce Corbus’s position as a leading candidate in the obesity therapeutic space.
The completion of Phase 1a and the initiation of Phase 1b mark a pivotal step in CRB‑913’s development. The favorable safety profile, early weight‑loss signal, and robust financial support position Corbus to advance the drug toward regulatory approval and ultimately to market, potentially reshaping the obesity treatment paradigm.
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