(Reuters) -Roivant and partner Priovant Therapeutics said on Wednesday that their experimental drug for a rare disease affecting both skin and muscle health has shown promising results in a late-stage clinical trial.
Shares of Roivant were up about 12% in premarket trading.
The drug, brepocitinib, was being tested for dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness, making everyday tasks difficult. If left untreated, the disease can severely impact a patient’s quality of life.
The companies said the drug showed improvement in both skin and muscle symptoms, reducing or stopping the need for steroids, which are commonly used to manage the disease but can cause long-term side effects.
In the trial, patients receiving a daily 30 mg oral dose of brepocitinib achieved a mean total improvement score of 46.5 after 52 weeks, compared to 31.2 for placebo. The difference was statistically significant, with benefits seen as early as week four, companies said.
Pfizer in 2021 licensed brepocitinib to Priovant Therapeutics, a joint company created with Roivant, where the former holds a 25% ownership stake, while Roivant leads the development of the drug.
According to the National Institutes of Health, dermatomyositis affects fewer than 5,000 people in the U.S. The condition has limited treatment options, with patients mainly relying on steroids and other immune system drugs.
Octapharma’s Octagam 10% is the only FDA-approved treatment for the condition.
The companies plan to file for U.S. approval in the first half of 2026.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
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