CRB-913 / Corbus Pharma - LARVOL DELTA

CANYON-1: A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity (clinicaltrials.gov) - P1 | N=252 | Recruiting | Sponsor: Corbus Pharmaceuticals Inc.

New P1 trial • Genetic Disorders • Obesity

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 (GlobeNewswire) - "Corbus Pharmaceuticals Holdings...announced the completion of the single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 and the initiation of a Phase 1b dose-range finding study ('CANYON-1'), with completion expected in summer 2026....CRB-913 was safe and well-tolerated across all doses studied. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participants. A placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12)."

P1 data • Obesity

Corbus Pharmaceuticals Holdings…announced the Company’s plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday, December 11, 2025 (GlobeNewswire)

P1 data • Obesity

CRB-913 is a second generation, highly peripherally restricted, oral small molecule CB1 receptor inverse agonist drug candidate designed for the treatment of obesity. (Corbus Pharmaceuticals Press Release) - "The Company is on track to complete the CRB-913 single ascending dose and multiple ascending dose (SAD/MAD) study and to initiate Phase 1b study in obese, non-diabetic patients by the end of this year."

New P1 trial • Obesity

Corbus Pharmaceuticals Initiates Multiple Ascending Dose Portion of Phase 1 Study of Highly Peripherally Restricted CB1 Inverse Agonist CRB-913 for the Treatment of Obesity (Corbus Pharmaceuticals Press Release) - "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 the treatment of obesity...The MAD portion of this clinical study is scheduled for completion in the third quarter of this year. The MAD portion of the Phase 1 trial is designed to test a once-daily dosing of CRB-913 for 7 days. Similarly to the SAD study, the MAD study is undertaken with healthy volunteers and focuses on safety, tolerability and PK of increasing doses of CRB-913. The study is being conducted in the United States...The SAD/MAD portion of the Phase 1 trial is scheduled to be completed in Q3 of 2025, and the Company expects to commence a Phase 1b dose-range finding study in Q4 of 2025. The dose-range finding study is scheduled for completion in the second half of 2026."

Trial status • Obesity

Corbus Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Study of Next-Generation CB1 Inverse Agonist CRB-913 for the Treatment of Obesity (GlobeNewswire) - "Corbus Pharmaceuticals Holdings, Inc...announced today the dosing of the first subject in the single ascending dose / multiple ascending dose (SAD/MAD) portion of the Phase 1 trial of CRB-913 for the treatment of obesity. The study is being conducted in the United States under an open IND....The SAD/MAD portion of the Phase 1 trial is scheduled to be completed in Q3 of this year and the Company expects to commence a Phase 1b dose-range finding study in Q4 of 2025. The dose-range finding study is scheduled for completion in the second half of 2026."

Trial completion date • Trial status • Obesity

Corbus Pharmaceuticals Reports Q4 and 2024 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-913 is a second-generation, highly peripherally restricted CB1 receptor inverse agonist drug designed to treat obesity....The Company expects to dose the first participant in the Phase 1 SAD/MAD study in March 2025. We expect to commence a Phase 1 dose-range finding study in the fourth quarter of 2025."

New P1 trial • Trial status • Obesity

Corbus Pharmaceuticals Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update (Corbus Pharmaceuticals Press Release) - "In a diet-induced obesity ('DIO') mouse model, CRB-913, as a monotherapy and in combination with incretin analogues (tirzepatide, semaglutide, or liraglutide), demonstrates a reduction in body weight in DIO mice and improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology....The Company is currently conducting IND enabling studies and expects to file an IND in the fourth quarter of 2024."

IND • Preclinical • Obesity

Corbus Pharmaceuticals Announces Publication of Data for its Novel Cannabinoid Type-1 Receptor Inverse Agonist in a Pre-Clinical Model of Obesity Along with Presentations at Obesity Week 2023 (GlobeNewswire) - "Corbus Pharmaceuticals Holdings, Inc...today announced results of a pre-clinical study on its CRB-913...have been selected for oral presentation at the 11th annual Obesity Journal Symposium, held during the 2023 Obesity Week Conference in Dallas, Texas October 14-17, 2023. In addition, the work has also been selected as a late breaking poster....CRB-913 demonstrated markedly enhanced plasma exposure and markedly reduced brain levels compared to the first generation CB1 inverse agonist rimonabant. CRB-913 monotherapy yielded dose-dependent decrease in body weight in DIO mice that was further enhanced in combination with tirzepatide, semaglutide, or liraglutide. Concomitantly, improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits and liver histology. All changes were statistically significant. CRB-913 did not induce any loss of lean mass."

Preclinical • Metabolic Disorders • Obesity

Novel cannabinoid receptor 1 inverse agonist CRB-913 enhances efficacy of tirzepatide, semaglutide, and liraglutidein the diet-induced obesity mouse model. (PubMed, Obesity (Silver Spring)) - "CRB-913 in combination with incretin analogues could deliver meaningful improvements over current standards of care for obesity and related conditions."

Journal • Preclinical • Genetic Disorders • Obesity

A novel oral cannabinoid receptor-1 inverse agonist induces additive weight loss and improves metabolic biomarkers in DIO mice in combination with semaglutide or tirzepatide (EASD 2022) - "CRB-913 demonstrated markedly reduced brain penetration compared to rimonabant and has potential to overcome the clinical safety challenges previously associated with CB1 inverse agonists. The combination of CRB-913 with incretin receptor agonists such as semaglutide and tirzepatide is additive and as such could provide a novel therapeutic strategy that could overcome some constraints observed with these agents as high dose monotherapies. The combination of two such orthogonal mechanisms of action merits exploration in clinical settings."

Combination therapy • Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • LEP