Roivant and Pfizer Unveil Priovant Therapeutics and Ongoing Registrational Studies for Oral Brepocitinib in Dermatomyositis and Lupus

NEW YORK– Roivant 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.

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 2H 2023.

“Roivant has a proven track record in late-stage inflammation and immunology drug development, which is why we are confident that Priovant will successfully continue the development of much needed innovative treatments for these patients,” said Mikael Dolsten, Chief Scientific Officer, President, Worldwide Research, Development and Medical at Pfizer. “This collaboration will enable allocation of resources to advance development of brepocitinib while allowing Pfizer to focus on diversifying its pipeline so that patients may benefit from potential options against inflammatory diseases.”

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.

“There is an urgent need for novel, targeted therapies for dermatomyositis, a devastating disease with few safe and effective treatments,” said Ruth Ann Vleugels, MD, MPH, Director of the Connective Tissue Disease Clinics and Autoimmune Skin Diseases Program at Brigham and Women’s Hospital/Harvard Medical School. “Brepocitinib is a particularly promising agent, as its dual inhibition of TYK2 and JAK1 may result in superior blockade of type I interferon, a key cytokine family implicated in dermatomyositis pathogenesis.”

Oral brepocitinib is being evaluated in a large, global Phase 2b study in SLE, designed to serve as one of two registrational studies. Lupus is a clinically heterogeneous autoimmune disease that can impact nearly all major organ systems. While there are two approved targeted biologics for lupus, many patients respond inadequately. Like dermatomyositis, lupus pathobiology is characterized by dysregulations in type I interferon and other TYK2- and JAK1-mediated proinflammatory cytokines.

In addition to brepocitinib, Pfizer has also licensed ropsacitinib, a selective TYK2 inhibitor, to Priovant.