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Corbus Pharmaceuticals Completes Enrollment in DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis
12-month, double-blind, placebo-controlled, multi-national study enrolled 176 participantsTopline results expected in fourth quarter of 2021 Dermatomyositis
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"12-month, double-blind, placebo-controlled, multi-national study enrolled 176 participantsTopline results expected in fourth quarter of 2021 Dermatomyositis is a rare, systemic autoimmune disease with characteristic skin and muscle involvement, serious morbidity, and increased mortality Norwood, MA, Aug. 05, 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 the completion of subject enrollment in DETERMINE, a Phase 3 study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis (“DM”). The Company expects to report topline results from this study in the fourth quarter of 2021.\n “We are grateful to the participants for their commitment and to all of our investigators and their staff for their support of the study and dedication to completing enrollment on time, despite COVID-19,” said Barbara White, M.D., Chief Medical Officer of Corbus. “Enrollment exceeded our expectations, which we think speaks to the unmet need of dermatomyositis patients for new treatment options, especially options without some of the toxicities associated with chronic immunosuppression.” The Company’s Phase 3 DETERMINE study has enrolled 176 subjects in the largest, randomized, double-blind, placebo-controlled DM study to date. This study is being conducted in North America, Europe, and Asia. Patients in the study are randomized 2:1:2 to either receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day or placebo twice per day for 52 weeks with a follow-up period of 4 weeks. The primary endpoint of DETERMINE is efficacy of lenabasum compared to placebo as measured by the American College of Rheumatology (“ACR”)/ European League Against Rheumatism 2016 Total Improvement Score (“TIS”) in myositis at 52 weeks, a weighted composite measure of improvement from baseline in six core set items that include physician directed assessments of Physician Global Activity, Manual Muscle Testing-8, and Extramuscular Global Activity, patient-reported outcomes of Patient Global Activity and Health Assessment Questionnaire, and biomarkers of muscle enzymes.ǂ Multiple secondary outcomes including Cutaneous Dermatomyositis Activity and Severity Index a...