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Corbus Announces Publication of Lenabasum Systemic Sclerosis Double-Blind, Placebo-Control Phase 2 Clinical Trial Results in Arthritis & Rheumatology
These previously presented data demonstrated lenabasum improved efficacy outcomes and underlying disease pathology compared to placebo and had an acceptable
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"These previously presented data demonstrated lenabasum improved efficacy outcomes and underlying disease pathology compared to placebo and had an acceptable safety profile in Phase 2 studySystemic sclerosis is a rare autoimmune disease affecting ~200,000 people in the U.S., EU and Japan, and has the highest mortality rate among the systemic autoimmune diseases Phase 3 study of lenabasum for the treatment of systemic sclerosis is on track for topline results in summer 2020 Norwood, MA, April 29, 2020 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system (ECS), today announced the publication of results from the double-blind, randomized, placebo-controlled Phase 2 trial assessing the safety and efficacy of lenabasum in 42 patients with diffuse cutaneous systemic sclerosis in Arthritis & Rheumatology. The paper [doi:10.1002/art.41294] is titled “Safety and efficacy of lenabasum in a Phase 2 randomized, placebo-controlled trial in adults with systemic sclerosis.” As previously reported, data showed treatment with lenabasum was associated with improvements across the primary endpoint, the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (ACR CRISS) score and multiple secondary efficacy outcomes. The study results also demonstrated that lenabasum has an acceptable safety profile.\n Efficacy and safety of lenabasum in systemic sclerosis are currently being evaluated in Corbus’ global, 365-subject, RESOLVE-1 Phase 3 study. Baseline characteristics of subjects are similar to those in the Phase 2 study. RESOLVE-1 has enrolled 365 individuals with SSc in an international, multicenter, randomized, double-blind, placebo-controlled study. The primary efficacy endpoint is ACR CRISS score. The study is also evaluating multiple secondary endpoints, including changes in HAQ-DI, mRSS and FVC percent predicted. Topline data from the RESOLVE-1 study remain on track for summer 2020. About LenabasumLenabasum is a rationally designed, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) and has been designed to resolve inflammation, limit fibrosis and support tissue repair. CB2 is preferentially ex...