Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”
Roivant Sciences and subsidiary Priovant’s TYK2/JAK inhibitor brepocitinib—recently approved for an autoimmune skin disease—significantly reduced the need for steroid treatment in patients with non-infectious uveitis in a pair of Phase 3 studies.
The results are a “clean win . . . with much better efficacy than AbbVie’s Humira,” currently the only approved non-steroid treatment for non-infectious uveitis (NIU), Leerink Partners said in a Wednesday afternoon note. Caused by viral, bacterial, fungal or parasitic infection of the uveal tract, NIU can cause pain, redness, photophobia and blindness.
Roivant, which hunts and acquires existing assets to develop on its own, licensed brepocitinib from Pfizer in a joint deal that spun off Priovant in 2022. Priovant gained approval in August for brepocitinib—to be marketed as Lisraya—to treat the autoimmune skin disease dermatomyositis, and the company is now seeking the regulatory go-ahead in NIU based on two identical Phase 3 clinical trials called Clarity-1 and Clarity-2.
Patients taking brepocitinib in both studies went more than 48 weeks before treatment failure—which captures tolerability and efficacy by measuring the time it takes for patients to stop taking the drug for any reason—compared with just 12 weeks for patients on placebo, meeting the trials’ primary endpoints, Roivant reported on Wednesday. Patients in the treatment arm went 40 weeks without requiring steroids, which set a “new bar” for noninfectious uveitis therapies, according to the company.
Pooled analysis across the Clarity program saw 62% of patients on brepocitinib remain steroid-free at 48 weeks, compared to 20% on placebo.
Leerink noted that 50% of patients fail on Humira within six months. Although the studies did not pit the two drugs against one another, the analysts said that brepocitinib “looked superior to Humira on a cross-trial basis with a much more aggressive steroid tapering schedule.”
Brepocitinib’s effectiveness spanned a number of different patient subgroups, including those with or without experience taking a tumor necrosis factor (TNF) inhibitor such as Humira and those with forms of uveitis including idiopathic disease, the sight-threatening visual condition birdshot chorioretinopathy and the inflammatory disease sarcoidosis.
Brepocitinib also met all of the trials’ secondary endpoints, including measurements of sustained steroid-free disease inactivity, chorioretinal vascular leakage—or the abnormal escape of fluid and plasma from blood vessels into the retina— and patient-reported visual aptitude. The drug candidate also resolved macular edema in 42% of eyes in patients who the condition in addition to uveitis, compared with just 4.8% on placebo.
Only 3% of participants discontinued brepocitinib because of an adverse event, most of which were mild or moderate, according to the company.
“The breadth and magnitude of benefit seen in the Clarity studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis,” Priovant CEO Ben Zimmer said in a prepared statement. “With Lisraya now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise.”
Priovant plans to file a supplemental application for the drug in NIU in the first half of 2027. Leerink analysts said Roivant management is exploring a first-line approach for brepocitinib in NIU, particularly as the studies showed largely consistent benefit in patients who had previously taken a TNF inhibitor and those in the overall treatment population.
The analysts have projected sales of $54 million for Lisraya in dermatomyositis, and $559 million in fiscal year 2028. For non-infectious uveitis, the analysts modeled $2.3 billion in unadjusted sales by the end of 2029, skewing higher if the drug receives a label friendly to patients who have not taken a TNF inhibitor like Humira.
Brepocitinib is one leg of a “three-legged stool,” making up the clinical and commercial prospects at the hub-and-spoke pharma conglomerate, Roivant CEO Matt Gline told BioSpace earlier this month. The other two legs are the pulmonary hypertension candidate mosliciguat, which is currently in a late-stage study after succeeding in Phase 2, and a mid- to late-stage anti-inflammatory drug candidate called IMVT-1402.
Gline told BioSpace prior to the readout that he expected the NIU readout to give brepocitinib “another brick to build a big wall.”
