Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (‘Corbus’ or the ‘Company’), a clinical stage drug development company with the industry’s leading pipeline focused on treating inflammatory and fibrotic diseases through the endocannabinoid system (‘ECS’) pathways, announced today the start of the Company’s Phase 3 trial, titled ‘DETERMINE,’ designed to evaluate the efficacy and safety of its investigational drug lenabasum for the treatment of dermatomyositis (‘DM’).
The Phase 3 study design is consistent with guidance from the U.S. Food and Drug Administration (‘FDA’) at an end-of-Phase 2 meeting, formal consultation with Japanese regulatory authorities (‘PMDA’), and scientific advice from European regulatory authorities. Dermatomyositis is a rare and serious multisystem inflammatory autoimmune disease that characteristically affects muscle and skin and can also involve the lungs, heart, joints, and gastrointestinal tract. The disease is characterized by significant morbidity, disability, and mortality despite the current standard-of-care treatment with corticosteroids or other immunosuppressive medications.
‘We are delighted to have achieved many important regulatory and clinical milestones in the development of lenabasum this year, now including the initiation of this Phase 3 DM study,’ said Barbara White, M.D., Chief Medical Officer of Corbus. ‘The double-blinded placebo-controlled 1-year study is designed to include subjects with active muscle and/or skin disease who represent the clinical spectrum of DM, making results applicable to the broad DM population. If the efficacy data from this single Phase 3 study are positive and the safety profile continues to be favorable, we intend to approach regulatory authorities about a registration package for lenabasum for treatment of DM.’
The DETERMINE Phase 3 study will test efficacy and safety of lenabasum in approximately 150 adults with DM. Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 52 will be Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints, including Physician Global Assessment of Disease Activity, Physician Global Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing, and muscle enzymes. Evaluation of key organ involvement – muscle, skin, and lungs, will be included in secondary efficacy outcomes. Change from Baseline in the Cutaneous Dermatomyositis Activity and Severity index (‘CDASI’) activity score will be a secondary efficacy outcome.
