October 23, 2020 -- The U.S. Food and Drug Administration (FDA) granted Kezar Life Sciences orphan drug designations (ODD) for its KZR-616 drug for treating polymyositis and dermatomyositis.
Both diseases are autoimmune inflammatory myopathies that are chronic and debilitating, characterized by marked morbidity and mortality. KZR-616 is a selective immunoproteasome inhibitor with the potential to affect multiple drivers of immune-mediated diseases and inflammation, the firm said.
Research from phase IA and IB trials shows KZR-616 has a favorable safety and tolerability profile for development in chronic autoimmune diseases. Presidio, a phase II placebo-controlled cross-over clinical trial to evaluate KZR-616 for the treatment of polymyositis and dermatomyositis, is currently enrolling patients, Kezar said.
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