Roivant Sciences Ltd ROIV and Priovant's Phase 2 study of oral brepocitinib in moderate to severe active lupus did not meet its primary endpoint of Systemic Lupus Erythematosus (SLE) Responder Index change of 4 (SRI-4) at Week 52.
Priovant plans to disclose the study data at a future date.
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"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," said Matt Gline, CEO of Roivant.
Priovant plans to continue progressing the program in indications outside of Systemic Lupus Erythematosus (SLE).
Priovant expects to announce topline results from its studies, the Phase 2 POC study of brepocitinib in non-infectious uveitis (NIU), in the first quarter of calendar year 2024 and the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.
Oral brepocitinib has demonstrated statistically significant clinically meaningful benefit in six completed placebo-controlled Phase 2 studies in psoriasis, psoriatic arthritis, alopecia areata, hidradenitis suppurativa, ulcerative colitis, and Crohn's disease.
In February 2023, Roivant Sciences announced that its founder Vivek Ramaswamy has stepped down from board of directors to focus on his U.S. presidential campaign.
In January 2021, Vivek Ramaswamy transitioned out of his day-to-day role as CEO of the company. He served as Roivant’s Chairman until February 20, 2023.
Price Action: ROIV shares are down 3.50% at $8.81 on the last check Monday.
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