Roivant Bids Farewell to Lupus Treatment Following Phase 2 Failure

Roivant CEO Matt Gline had never been too confident of lupus drug brepocitinib. As early as the start of the year, he expressed that individuals not apprehensive about a lupus study may lack wisdom, and their judgment might be questionable. Roivant’s Priovant unit will now discontinue the lupus indication while persisting with brepocitinib for several other conditions, including non-infectious uveitis (NIU).

Now, it appears that Gline’s apprehension was justified. The treatment, acquired from Pfizer in 2022, did not yield improvements in lupus disease occurrence at week 52, falling short of the primary objective in a phase 2 study. 

Gline, in an official statement, attributed the setback to a significant placebo response observed in the trial. The evaluation of brepocitinib involved adult patients dealing with moderate to severe active systemic lupus erythematosus, using the widely recognized Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4) to assess efficacy.

Gline said “We saw some of the highest SRI-4 responder rates ever observed in a lupus study in the active arm of this trial, along with a favorable safety and tolerability profile. Unfortunately, we also saw the highest placebo response rate observed in any significant SLE study, and as such it was not possible to truly assess the impact of the drug, or to establish sufficient differentiation from other therapies in lupus patients.”

Last year, Roivant established Priovant in collaboration with Pfizer, focusing on brepocitinib and the TYK2 inhibitor PF-06826647 (ropsacitinib). Pfizer maintains a 25% ownership stake in Priovant. While specific data remains undisclosed, Priovant anticipated that phase 2 study results would support lupus approval for brepocitinib. Despite a setback in the lupus indication, the company is now directing its focus towards the broader brepocitinib program. The TYK2 inhibitor is undergoing phase 2 testing for non-infectious uveitis, with results expected in Q1 2024. 

Additionally, a phase 3 readout for dermatomyositis is anticipated in 2025. Roivant reported potential advantages of brepocitinib in six placebo-controlled mid-phase tests, covering conditions like ulcerative colitis, alopecia areata, psoriasis, hidradenitis suppurativa, Crohn’s disease, and psoriatic arthritis.

Roivant reported that brepocitinib has displayed potential advantages in six placebo-controlled mid-phase tests covering ulcerative colitis, alopecia areata, psoriasis, hidradenitis suppurativa, Crohn’s disease and psoriatic arthritis.

Gline emphasized that the recent results indicate brepocitinib’s high activity level along with a favorable safety profile.

Roivant joins a list of companies encountering challenges in lupus research. Horizon Therapeutics, acquired by Amgen in October, faced a phase 2 setback in July. The company said its lupus candidate  failed to demonstrate a significant difference in the assessment of disease activity compared to the placebo, as per the results unveiled on Friday. While numerical variances were observed in other endpoints during the phase 2 trial, the biotech noted there were no safety concerns to report.

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