Corbus Pharmaceuticals Reports Last Subject Visit in DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis

• Topline data on schedule for Q2 2021
• Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, and affects ~80,000 people in North America, EU, and Japan
• There is a significant need for safer and more effective treatments in dermatomyositis because of limitations of current treatment options

Norwood, MA, March 30, 2021 (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 the final visit in the double-blind, placebo-controlled part of the Company’s Phase 3 DETERMINE study of lenabasum for the treatment of dermatomyositis. The open-label extension of the study is ongoing. Topline results from the study are on track to be reported in the second quarter of 2021.

The Phase 3 trial is an international, 176-subject study evaluating the safety and efficacy of lenabasum in adult dermatomyositis patients who are receiving standard treatments, including background immunosuppressive therapies. This study is the largest randomized, double-blind, placebo-controlled dermatomyositis study to date. Subjects were randomized 2:1:2 to either receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day.

The primary efficacy endpoint is the composite American College of Rheumatology/European League Against Rheumatism 2016 Total Improvement Score (“Total Improvement Score”) at Week 28. Change from baseline will be provided for each component of the Total Improvement Score to support this composite endpoint. Definition of Improvement, Investigator Global Assessment scale of skin activity, and Cutaneous Dermatomyositis Activity and Severity Index activity score are among secondary efficacy endpoints.

Lenabasum was granted Orphan Drug Designation for the treatment of dermatomyositis from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

About Lenabasum

Lenabasum is a novel, oral, small molecule designed to provide an alternative to immunosuppressive treatments for inflammatory or fibrotic diseases. Lenabasum binds to and activates the cannabinoid receptor type 2 (CB2), which is preferentially expressed on activated immune cells, to resolve inflammation and limit fibrosis. Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. In clinical testing to date, lenabasum has an acceptable safety and tolerability profiles without evidence of immunosuppression.