Undisclosed CB2 agonist / Corbus Pharma - LARVOL DELTA

Cannabinoid receptor 2 agonist, lenabasum, for the treatment of pulmonary exacerbations in cystic fibrosis. (PubMed, J Cyst Fibros) - "Lenabasum did not improve key clinical outcomes in this Phase 2b study in pwCF."

Clinical • Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Evaluating the Abuse Potential of Lenabasum, a Selective CB2 Cannabinoid Receptor Agonist. (PubMed, J Pharmacol Exp Ther) - "CB1 and CB2 agonists exhibit broad anti-inflammatory properties, suggesting their potential to treat inflammatory diseases...Three doses of lenabasum (20, 60, and 120mg) were compared to placebo, and nabilone (3 and 6mg)...Significance Statement This work provides evidence that in people with a history of recreational cannabis use, lenabasum was safe and well-tolerated, although it did demonstrate abuse potential. This work supports further development of lenabasum for potential therapeutic indications."

Journal • CNS Disorders • Inflammation

Session III Treatment of Dermatomyositis: Safety of lenabasum in the Phase 3 DeterMine Trial in dermatomyositis (DM) (ISID 2023) - "Lenabasum, a CB2agonist that activates resolution of inflammation, improved skin disease, patient-reportedoutcomes, and biomarkers in a Phase 2 study of DM patients with active skin disease.The objective was to evaluate the efficacy and safety of lenabasum in a Phase 3 doubleblind study in DM. When restricting analysis ofparticipants without muscle weakness (MMT-8 = 150), improvement in CDASI activityscore was greater in the lenabasum 20 mg BID group vs placebo at Week 28, p = 0.0461,and Week 52, p = 0.0059. Related TEAEs leading to withdrawal of study product wereinfrequent."

Clinical • P3 data • Dermatology • Dermatomyositis • Immunology • Myositis

Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis (ACR Convergence 2022) - "Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported outcomes, and biomarkers in a Phase 2 study of DM patients with active skin disease. DM patients ≥ 18 years old with active skin with or without muscle involvement were enrolled in 55 sites in North America, Europe, and Asia-Pacific. Although, primary or secondary endpoints were not met in the study, subgroup analysis of patients with muscle weakness and without muscle weakness, showed improvement in muscle strength and rash, respectively in lenabasum 20 mg BID group vs placebo. Lenabasum was administered safely and was well-tolerated in this study.Figure 1. Change over time of entire study population: A. TIS; B. CDASI-A."

Clinical • P3 data • Dermatology • Dermatomyositis • Immunology • Inflammation • Musculoskeletal Pain • Myositis • Pain

Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis (EULAR 2022) - "Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported outcomes, and biomarkers in a Phase 2 study of DM patients with active skin disease. Although, primary or secondary endpoints were not met in the study, subgroup analysis of patients with muscle weakness and without muscle weakness, showed improvement in muscle strength and rash, respectively in lenabasum 20 mg BID group vs placebo. Lenabasum was administered safely and was well-tolerated in this study."

Clinical • P3 data • Dermatology • Dermatomyositis • Immunology • Musculoskeletal Pain • Myositis • Pain