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Roivant and Pfizer Unveil Priovant Therapeutics and Ongoing Registrational Studies for Oral Brepocitinib in Dermatomyositis and Lupus
Brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1; in all five placebo-controlled studies completed to date, oral
About this update from Roivant Sciences Ltd.
[{"type":"text","content":"\n\nBrepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1; in all five placebo-controlled studies completed to date, oral brepocitinib generated statistically significant and clinically meaningful results \n\n\nPriovant is developing brepocitinib in severe autoimmune diseases with few approved therapies and where dual inhibition of TYK2 and JAK1 may provide greater efficacy than inhibiting either alone\n\n\nA single registrational Phase 3 trial evaluating oral brepocitinib in dermatomyositis (VALOR) was initiated earlier this quarter\n\n\nAn ongoing Phase 2b study in systemic lupus erythematosus (SLE), designed to serve as one of two registrational studies, is expected to generate top-line results in 2H 2023\n\n\n NEW YORK--(BUSINESS WIRE)--\nRoivant Sciences and Pfizer today 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 (Nasdaq: ROIV) and Pfizer (NYSE: PFE), 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.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220628005336/en/\nBrepocitinib 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 2H 2023.\n\n“Roivant has a proven track record in late-stage inflammation and im...