Negative results from phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis .- Corbus Pharmaceutical Holdings Inc.

Corbus Pharmaceuticals Holdings, Inc. announced topline results from the 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc) . SSc is a rare and life-threatening multi-system autoimmune disease for which there are currently no FDA-approved treatments for overall disease.Topline data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo , both added to background drug therapy. For the primary endpoint, the median American College of Rheumatology Combined Response Index for Systemic Sclerosis (ACR CRISS) scores at Week 52 were 0.887 in the placebo arm and 0.888 in the lenabasum 20 mg twice daily arm. ACR CRISS is a composite endpoint that reflects the probability of patient improvement. The maximum achievable ACR CRISS score is 1.0. RESOLVE-1 is the first 52-week, randomized, placebo-controlled Phase 3 trial that tested the efficacy and safety of lenabasum in 365 patients with diffuse cutaneous SSc in a multinational, double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 20 mg twice daily, lenabasum at 5 mg twice daily, or placebo twice daily for 52 weeks. The majority of enrolled patients (84%) were receiving background immunosuppressive drugs, reflecting recent trends in clinical practice. Similar proportions of placebo-treated and lenabasum-treated subjects had at least one treatment emergent adverse event (AEs), 86.2% in the placebo arm and 91.7% in the lenabasum 20 mg twice daily arm. Serious AEs occurred in 14.6% of subjects in the control arm and 9.2% of subjects in the lenabasum 20 mg twice daily arm. Severe AEs occurred in 13% of subjects in the control arm and 5.8% of subjects in the lenabasum arm. No subjects receiving lenabasum withdrew from the study because of an AE-related to study drug. Lenabasum treatment was well-tolerated in this study. No evidence of lenabasum-related immunosuppression or new safety signals for lenabasum were observed. Further analyses of these data are underway, and once Corbus has a fuller understanding of the data, the Company would like to engage with the FDA to determine potential next steps in this clinical development program. The data will be presented at upcoming medical conferences.