Corbus Pharmaceuticals (NASDAQ:CRBP) updated data from its Phase 3 study of lenabasum for the treatment of systemic sclerosis.
Systemic sclerosis is an autoimmune disease characterized by inflammation and fibrosis. Lenabasum is an oral cannabinoid receptor type 2 receptor agonist designed to resolve inflammation and limit fibrosis.
The study enrolled 365 diffuse cutaneous systemic sclerosis patients on background drug therapy who were randomized to receive either 5 mg or 20 mg of lenabasum, or placebo, twice daily for 52 weeks. The primary efficacy endpoint was the median combined response index for systemic sclerosis scores at week 52.
Topline data reported in September 2020 showed no significant difference in the primary endpoint when comparing lenabasum with placebo. However, post-hoc analyses demonstrated that patients receiving 20 mg of lenabasum twice daily had a reduced decline in forced vital capacity at one year, compared with those receiving placebo.
“We are encouraged by the post-hoc analyses pointing to lenabasum’s therapeutic potential to reduce decline in lung function in people with systemic sclerosis who have been on longer-term immunosuppressant drug therapy,” Yuval Cohen, Ph.D., Corbus’ CEO, said in a statement.
“We believe these findings offer a rationale for additional clinical development of lenabasum, a non-immunosuppressive agent, that could address lung function decline in systemic sclerosis patients,” he added.
