Published: Jun 28, 2022
By Vanessa Doctor, RN
Pfizer and Roivant Sciences unveiled a new company called Priovant Therapeutics to develop and market new therapies for a wide range of autoimmune diseases with high mortality and morbidity rates.
Priovant was created in September 2021 when Pfizer partnered with Roivant. The agreement involved Pfizer licensing global development rights and U.S. and Japan commercial rights for the oral and topical version of brepocitinib to Priovant. Brepocitinib is a TYK2 and JAK1 dual inhibitor that has demonstrated strong efficacy rates against many highly inflammatory autoimmune disorders compared to therapies that inhibit just TYK2 or JAK1 alone.
Priovant, which is 25% owned by Pfizer, is developing brepocitinib’s oral version as a franchise across various orphan and specialty disorders. The drug is currently being studied in two registrational programs, including a global Phase IIB study in systemic lupus erythematosus (SLE) which is expected to be fully enrolled by the second half of 2023.
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Oral brepocitinib has also been studied in 14 Phase I and Phase II trials for various possible indications, such as plaque psoriasis, psoriatic arthritis, alopecia areata, ulcerative colitis and hidradenitis suppurativa.
“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,” Mikael Dolsten, chief scientific officer and president for worldwide research, development and medical at Pfizer, said in a statement.
“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,” he added.
Apart from SLE, Priovant is conducting a Phase III registrational VALOR trial for the oral drug versus dermatomyositis, an immune-mediated disease affecting the muscles and skin. People with this disorder usually manifest skin rashes and severe muscle weakness, which can later worsen into disfigurement and functional damage. The five-year mortality rate for this disease is 10 to 40%.
The VALOR trial tests brepocitinib in dermatomyositis patients ages 18 to 74 who have been taking a consistent dose of medications for their disease. Those in the brepocitinib group are to take three tablets every morning. The randomized trial is designed to last up to 64 weeks, with 11 clinic visits for monitoring, interviews and tests.
“There is an urgent need for novel, targeted therapies for dermatomyositis,” Ruth Ann Vleugels, M.D., M.P.H., director of the connective tissue disease clinics and autoimmune diseases program at Brigham and Women’s Hospital/Harvard Medical School, said. “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.”