Corbus Pharmaceuticals announced today that the European Union has approved orphan designation for lenabasum for the treatment of dermatomyositis. Lenabasum received orphan drug status in the US earlier this year, providing incentives for the continued drug testing necessary for FDA approval.
Like the US, the EU grants orphan designation to drugs that are intended for the treatment of life-threatening or chronically debilitating rare diseases where no satisfactory therapy is currently available.
Lenabasum is a synthetic, oral, non-psychoactive cannabinoid receptor type 2 (CB2) agonist that has shown significant promise for treating dermatomyositis in earlier clinical trials. The drug works by resolving inflammation and fibrosis and halting the production of additional inflammation. One of the values of this treatment is that it does not suppress inflammation like prednisone and other myositis medications, and it has few side effects.
Phase 2 studies in diffuse cutaneous systemic sclerosis (scleroderma), dermatomyositis, and cystic fibrosis suggest that the drug may have clinical benefit. Additional clinical studies are being conducted and/or planned to confirm these preliminary results and support applications for regulatory approval in both the US and in Europe.
See the company’s press release here.