Results of phase 2 study suggest clinical benefit and favorable safety profile, warranting further study of lenabasum for DM
TUESDAY, Oct. 11, 2022 (HealthDay News) — Lenabasum is well tolerated for the treatment of amyopathic dermatomyositis, according to a phase 2 study published online Oct. 1 in the Journal of Investigative Dermatology.
Victoria P. Werth, M.D., from the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues evaluated the safety and efficacy of lenabasum in patients with refractory cutaneous dermatomyositis. The analysis included 22 participants randomly assigned to lenabasum (11 participants) or placebo (11 participants) for a regimen of lenabasum daily for 28 days (all participants) and then either lenabasum or placebo twice per day for 56 days.
The researchers observed no serious or severe adverse events related to lenabasum, and no participants discontinued the study. In the lenabasum group, the adjusted least-squares mean for Cutaneous Dermatomyositis Disease Area and Severity Index activity decreased more, with the difference reaching significance on day 113.
“Current treatments, which are limited and can involve frequent and costly intravenous infusions, are not always effective in treating its dermatological manifestations and can produce side effects,” Werth said in a statement. “Our research showed that the cannabinoid receptor type 2 agonist lenabasum works to improve the skin of patients with amyopathic dermatomyositis in a short period of time. The identification of a well tolerated and effective oral medication greatly expands treatment options for patients with refractory skin disease.”
The study was partially funded by Corbus Pharmaceuticals, the developer of lenabasum, and several authors disclosed financial ties to the company.
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