Brepocitinib

Joint pain anatomy medical concept iStock, Cinefootage Visuals Brepocitinib remains “ahead of competition” in the dermatomyositis space, according to analysts at Leerink, who projected that the drug candidate could hit $2 billion in sales in 2032. Roivant’s TYK2/JAK1 dual inhibitor brepocitinib hit its primary and all nine key secondary endpoints in patients with dermatomyositis in the Phase III VALOR trial. With these data, Roivant and its Pfizer-backed subsidiary Priovant are heading to the FDA with an expected filing in the front half of 2026. Based on these plans, Leerink Partners told investors on Wednesday that Roivant is “on track to be launching a blockbuster drug” in the first quarter of 2027. The analysts were bullish about brepocitinib’s market prospects, raising their 2032 sales projection from a previous estimate of $1.4 billion to $2 billion. “Brepocitinib is ahead of competition” in dermatomyositis, Leerink wrote, including Argenx’s subcutaneous efgartigimod, AstraZeneca’s anifrolumab and even Pfizer’s own dazukibart. All three assets have late-stage readouts planned for the second half of 2026 or later, the analysts added. Shares of Roivant were up 7.76% at close of trading Wednesday . Results announced on Wednesday demonstrated that brepocitinib elicited significantly stronger clinical response than placebo, as measured by the Total Improvement Score (TIS). Patients treated with the investigational drug hit a mean TIS of 46.5 at 52 weeks, versus 31.2 in patients who received placebo. This effect was statistically significant, with “nearly twice as many patients” on brepocitinib able to discontinue background steroid treatment. Brepocitinib’s therapeutic benefits were evident as early as week 4, according to Wednesday’s release, and the drug hit all nine key secondary endpoints, including skin, motor strength and functional performance. Leerink in its investor note did say that brepocitinib’s outcomes came “slightly below our initial hope” of a 20-point advantage on the TIS scale. Still, the analysts said the overall pro brepocitinib is good “given the totality of the data.” In particular, the firm pointed to the high rate of steroid discontinuation in the brepocitinib group. The analysts added that the drug also “demonstrated compelling muscle efficacy, a key driver for clinical adoption and commercial success.” VALOR data on Wednesday also pointed to an overall favorable safety profile. Side effects of interest, such as malignancies and cardiovascular events, were balanced between brepocitinib and placebo arms. Dermatomyositis is a rare inflammatory condition that causes muscle weakness and skin irritation. It occurs in about 13 of every 100,000 people . Designed to be taken orally, brepocitinib is a dual inhibitor of the TYK2 and JAK1 pathways, giving it potent anti-inflammatory effects. In June 2022, Roivant and Pfizer tied up to launch Priovant Therapeutics, a subsidiary dedicated to the clinical development of brepocitinib.

Priovant Therapeutics’ management plans to file for approval of brepocitinib in dermatomyositis in the first half of next year. \n A phase 3 trial of Priovant Therapeutics’ inflammatory disease prospect brepocitinib has hit its primary endpoint, setting the Roivant-backed biotech up to seek FDA approval for the TYK2/JAK1 inhibitor next year.Roivant created Priovant in 2022 after striking a deal with Pfizer for brepocitinib and the TYK2 inhibitor ropsacitinib. Brepocitinib moved into phase 3 around the same time, with researchers picking the rare muscle inflammation and skin rash condition dermatomyositis as the lead indication. The drug candidate hit a setback in 2023, when it failed a midphase lupus trial, but has bounced back with a pivotal victory.Priovant compared two doses of brepocitinib to placebo in 241 people with dermatomyositis. After 52 weeks of once-daily oral dosing, the company saw a mean Total Improvement Score (TIS) of 46.5 on the high dose compared to 31.2 for placebo, achieving the primary endpoint of the trial.More than two-thirds of patients on the high dose had at least a moderate response to the molecule, as defined by a TIS of 40 or greater. Almost half had a TIS of 60 or greater, which Priovant classed as a major response. Cutaneous clinical remission was seen in 44% of patients on the high dose compared to 21% of people on placebo. Priovant said brepocitinib beat placebo on all nine key secondary endpoints.  Brepocitinib improved outcomes over placebo while enabling more people to come off steroids. About three-quarters of participants were receiving background steroids at the start of the trial. By Week 52, 42% of patients on the high dose had come off steroids compared to 23% of people on placebo.Talking at a Morgan Stanley event this month, Roivant CEO Matthew Gline said all participants needed to taper steroids to “mitigate some of the placebo risk and give us a little bit more of a chance to separate.” At 31.2, the placebo TIS fell in the middle of the 20 to high 30s range that Gline said was seen in other trials.Priovant saw a consistent dose response between the 15-mg and 30-mg arms. The safety profile of the high dose was consistent with that seen in earlier brepocitinib studies. And, with adverse events of special interest such as malignancy, cardiovascular events and thromboembolic events being no more common on the high dose than on placebo, the biotech has chosen 30 mg as the optimal dose. Management plans to file for approval of brepocitinib in dermatomyositis in the first half of next year. The target positions Priovant to challenge Pfizer’s Octagam, an intravenous immunoglobulin that the FDA approved in dermatomyositis in 2021. Argenx is running a phase 2/3 trial of its FcRn drug Vyvgart Hytrulo in dermatomyositis and other forms of idiopathic inflammatory myopathy. Gline said that argenx is “maybe 18 months behind us or something like that.” The lead could give Priovant a window in which to establish its drug as a go-to treatment option for the 40,000 and 70,000 people that Gline estimates have the condition in the U.S. Gline said existing and potential future drugs cost between $250,000 and $500,000 a year, providing bookends for the pricing of brepocitinib.Dermatomyositis is the first of a set of potential indications for brepocitinib. Priovant is running a phase 3 trial in noninfectious uveitis and a midphase study in cutaneous sarcoidosis. The biotech began the phase 3 trial one year ago.