Priovant Therapeutics Initiates Registrational Studies for Oral Brepocitinib

Roivant Sciences and Pfizer have launched Priovant Therapeutics, a company focused on developing novel therapies for autoimmune diseases. The company has now initiated planned registrational studies for oral brepocitinib as a potential new treatment for dermatomyositis and systemic lupus erythematosus (SLE).

Brepocitinib is a dual, selective inhibitor of TYK2 and JAK1, a mechanism expected to offer greater efficacy in inflammatory autoimmune diseases compared to single inhibitors. Priovant holds the global development rights and U.S. and Japan commercial rights for brepocitinib. Pfizer retains a 25% equity stake in Priovant.

The registrational Phase 3 study for dermatomyositis, named VALOR, has commenced. Dermatomyositis is a rare autoimmune disease characterized by skin rash and muscle weakness, carrying a significant mortality risk. A Phase 2b study in SLE, intended to serve as one of two registrational studies, is expected to yield results in the second half of 2023.

Brepocitinib's safety profile has been evaluated in studies involving over 1,000 subjects. Roivant Sciences leverages its track record in late-stage inflammation and immunology drug development, collaborating with Pfizer to advance treatments for these unmet medical needs.