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Corbus Pharmaceuticals Reports Last Subject Visit in RESOLVE-1 Phase 3 Study of Lenabasum for Treatment of Systemic Sclerosis
Topline data on schedule for summer 2020Systemic sclerosis (SSc) is a rare, serious and life-threatening autoimmune disease affecting ~200,000 people in the
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Topline data on schedule for summer 2020Systemic sclerosis (SSc) is a rare, serious and life-threatening autoimmune disease affecting ~200,000 people in the U.S., EU and JapanThere are no FDA-approved therapies for the overall treatment of SSc Norwood, MA, May 27, 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, today announced that the last subject completed their final visit in the Company’s RESOLVE-1 Phase 3 trial of lenabasum for the treatment of systemic sclerosis. Topline results from the study are on track for summer 2020.\n “We would like to express our sincere gratitude to our staff, our clinical collaborators and the study participants for their commitment and dedication leading to the study completing on time even in the midst of a global pandemic,” said Yuval Cohen, Ph.D, Chief Executive Officer. The RESOLVE-1 Phase 3 trial is a multinational study evaluating the efficacy and safety of lenabasum in systemic sclerosis. This was a double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 20 mg twice per day, or lenabasum at 5 mg twice per day, or placebo twice per day for 52 weeks, with a 28-day safety follow-up. Study subjects may then elect to participate in the ongoing open-label extension of RESOLVE-1. The primary efficacy endpoint is a composite score known as the ACR CRISS, measured at Week 52. ACR-CRISS was also the primary endpoint in the preceding Phase 2 study recently published in Arthritis & Rheumatology. Secondary efficacy endpoints include change from baseline at Week 52 in modified Rodnan skin score, Health Assessment Questionnaire- Disability index, and forced vital capacity (FVC) percent predicted. Three hundred and sixty-five patients were enrolled in the study. Baseline disease characteristics of subjects in RESOLVE-1 are similar to those in the Phase 2 study and were recently presented at American College of Rheumatology (ACR) 2019 Annual Meeting and European League Against Rheumatism (EULAR) 2020 E-Congress. Lenabasum has been granted Orphan Drug designation and Fast Track designation for the treatment of systemic sclerosis from the U.S. Food and Drug Administration (FDA) and Orphan Designation for the t...