Roivant Sciences and Pfizer announced the unveiling of Priovant Therapeutics, dedicated to developing and commercializing novel therapies for autoimmune diseases with the greatest morbidity and mortality. Priovant was established in September 2021 through a transaction between Roivant and Pfizer, in which Pfizer licensed oral and topical brepocitinib's global development rights and US and Japan commercial rights to Priovant. Pfizer holds a 25% equity ownership interest in Priovant.

Brepocitinib is a potential first-in-class dual inhibitor of TYK2 and JAK1, a novel mechanism of action expected to potentially provide greater efficacy in multiple highly inflammatory autoimmune diseases, as compared to agents that inhibit either TYK2 or JAK1 alone. Priovant is developing oral brepocitinib as a franchise across multiple orphan and specialty autoimmune diseases with few approved therapies, high morbidity and mortality, and pathobiologies for which both TYK2 and JAK1 inhibition are expected to contribute to efficacy. Oral brepocitinib is being evaluated in two ongoing registrational programs. Priovant recently initiated a single registrational Phase 3 study in dermatomyositis (VALOR).

A large, global Phase 2b study in SLE, designed to serve as one of two registrational studies, is close to fully enrolled with data anticipated in second half of 2023. Oral brepocitinib has been evaluated in 14 completed Phase 1 and Phase 2 studies, including five placebo-controlled Phase 2 studies in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata, and hidradenitis suppurativa. All five of these placebo-controlled Phase 2 studies generated statistically significant and clinically meaningful results.

Oral brepocitinib's safety database includes over 1,000 exposed subjects and suggests a safety profile similar to those of approved JAK inhibitors. Priovant recently initiated a single registrational Phase 3 study evaluating oral brepocitinib in dermatomyositis (VALOR). Dermatomyositis is an immune-mediated disease of the skin and muscles.

Patients with dermatomyositis usually present with a characteristic skin rash and debilitating muscle weakness, which may lead to significant functional impairment and/or disfigurement. Substantially increased risk of interstitial lung disease, malignancy, and heart failure contribute to an estimated five-year mortality rate of 10-40%.(i) There is a substantial unmet need for novel, efficacious and convenient therapies that address the underlying pathophysiology of dermatomyositis.