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Corbus Pharmaceuticals Updates Data from Lenabasum Open-Label Extension Studies in Systemic Sclerosis and Dermatomyositis at 2019 ACR Annual Meeting
Median ACR CRISS score remains 0.95 at 25 months in systemic sclerosis OLE Improvement in CDASI activity score reaches -20.9 points at 23 months in
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"\n Median ACR CRISS score remains 0.95 at 25 months in systemic sclerosis OLE Improvement in CDASI activity score reaches -20.9 points at 23 months in dermatomyositis OLE Favorable safety profile continues with no serious or severe AEs related to lenabasum reported in these studies to dateTopline results from RESOLVE-1 Phase 3 study of lenabasum in systemic sclerosis expected summer 2020 Norwood, MA, Nov. 11, 2019 (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 continued favorable safety and efficacy outcomes in open-label extensions (OLE) of lenabasum Phase 2 studies in two rare and serious autoimmune diseases: systemic sclerosis (SSc) and dermatomyositis (DM). These data are being presented at the American College of Rheumatology (“ACR”) 2019 Annual Meeting being held November 8-13, 2019 in Atlanta, Georgia. “The persistently favorable safety profile and durable improvement in efficacy outcomes, with over 2 years of dosing in these OLEs, support our optimism that the Phase 3 SSc study will show positive data in summer 2020. We interpret the durable improvement in multiple efficacy outcomes as an indicator showing totality of benefit for these diseases. The high rate of subject retention in these OLEs speaks to the enthusiasm of both the patients and their physicians for lenabasum as a potential treatment for SSc and DM. We are deeply grateful to the patients, physicians and site staff participating in these studies,” said Barbara White, M.D., Chief Medical Officer and Head of Research for the Company. Efficacy and Safety Outcomes in Systemic Sclerosis OLE 29/36 (81%) of subjects who enrolled in the OLE were still enrolled at Month 25.ACR CRISS score remained ≥ 0.95 from Month 12 through Month 25 in the OLE. An ACR CRISS score of ≥ 0.60 at 1 year has been reported to be medically important.mRSS improved > 9.2 points during the same time. An improvement of -4 to -5 points in mRSS at 12 months has been reported to be medically important.Patient and physician global assessments of health, skin symptoms, itch, and patient-reported disability and function showed either stabilization or continued improvement during the OLE from Month 12 through 25.M...