Kezar KZR-616 gets FDA orphan drug designations for two autoimmune disease

Kezar Life Sciences’ (NASDAQ:KZR) KZR-616 received FDA orphan drug designation for the treatment of polymyositis and dermatomyositis, autoimmune inflammatory myopathies with marked morbidity and mortality.

KZR-616 is a selective immunoproteasome inhibitor designed to act on multiple drivers of immune-mediated diseases and inflammation. The company is currently enrolling patients in a Phase 2 trial to evaluate KZR-616 for the treatment of polymyositis and dermatomyositis.

“This recognition spotlights the significant unmet need for patients living with these autoimmune myopathies,” Dr. Noreen Henig, Kezar’s CMO, said in a statement.

“KZR-616 has potential to truly modify the underlying pathophysiology of these two diseases,” she added.