With the ink barely dry on Lisraya’s first approval, Roivant and its spinout Priovant are wasting little time in arguing for the dual TYK2/JAK1 inhibitor to inherit a larger immune-mediated kingdom.
This week, the companies announced wins across their late-stage Clarity-1 and Clarity-2 studies of once-daily brepocitinib in noninfectious uveitis (NIU), a form of eye inflammation that is one of the leading causes of blindness among working-age people.
Wins in hand, Roivant said Wednesday that Priovant plans to submit the data to the FDA in the first half of 2027, contending that the “magnitude and breadth” of benefit observed in the studies could give brepocitinib the “potential to be the most effective systemic, non-steroid treatment option for NIU.”
Corticosteroids aside, and apart from off-label use of other biologics, AbbVie’s Humira currently stands alone as the only systemic biologic treatment with an FDA approval specifically for NIU.
Now jockeying for that niche, an NIU green light would mark the second indication for brepocitinib, which was approved in late August as Lisraya for dermatomyositis (DM), an autoimmune condition characterized by progressive muscle weakness and extensive, painful and itchy skin lesions.
Clarity-1 and Clarity-2 ran as identical studies, enrolling 371 patients in total and setting time to treatment failure from week six through week 48 as the primary endpoint.
All told, Roivant and Priovant’s drug showed consistent benefits in preventing treatment failure versus placebo, even across multiple patient subgroups.
In Clarity-1, brepocitinib was tied to a 35.4% cumulative incidence of treatment failure at week 48, compared with a rate of 78.7% among patients on placebo. In Clarity-2, assessing the same 45-mg dose, Roivant’s medicine was linked to a 32.4% treatment failure incidence versus 77.8% in the control group.
Meanwhile, pooled data from the pair of studies found that 62% of patients on brepocitinib achieved steroid-free disease control at week 48, compared with 20% of participants on placebo.
And among patients who entered the studies with macular edema, 42% of eyes in the brepocitinib group showed resolution of the condition by week 48, again in pooled results, versus just 4.8% in the placebo group.
In framing that readout, analysts at Jefferies noted Wednesday that macular edema is “what’s driving the blindness” in NIU patients. The analyst shop said it was also impressed by the consistency of response seen with brepocitinib, its ability to stabilize NIU and the fact that “patients are coming off steroids while achieving all these benefits.”
If undertreated, NIU can cause permanent vision loss. Beyond that risk, the condition is often associated with eye pain, floaters and visual impairment of multiple types, including visual acuity, peripheral vision, color recognition and the ability to focus on moving objects, Roivant said.
The condition is estimated to affect 70,000 to 190,000 adults in the United States.
Analysts have already pinned blockbuster sales expectations on Lisraya, with Roivant noting in an investor presentation (PDF) Wednesday that it views the opportunity in NIU as comparable in size to its initial indication in DM.
In its Wednesday note to clients, Jefferies said that each indication Roivant is pursuing for Lisraya could represent an “at least” $1 billion to $3 billion peak sales opportunity, adding that it’s “easy to figure out brepo could ultimately be at least $10B peak sales in the US.”
Meanwhile, given that Roivant’s data looked good in both patients with and without prior exposure to tumor necrosis factor (TNF) inhibitors, the class to which Humira belongs, the analysts surmised that the Clarity data “indeed looks very strong on an apples-to-apples basis.”
The Jefferies team said it currently expects that payers would require NIU patients to “step through” Humira, which has biosimilar options available, before moving to an approved Lisraya for the disease. However, the analysts cautioned that the projection could be “conservative given how strong the data were today.”
More broadly, Roivant has framed its development efforts for Lisraya as a “multi-indication journey” and is already mapping out the path to two additional potential uses in cutaneous sarcoidosis and lichen planopilaris beyond DM and NIU.
Across the four indications, Roivant has projected a potential patient pool for Lisraya of around 280,000 people.