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Oral brepocitinib did not meet its number one endpoint of four replacements in the systemic lupus erythematosus (SRI-four) reaction index at week 52.
Priovant expects to continue advancing the program in external indications for systemic lupus erythematosus (SLE) given the drug’s favorable protection and tolerability profile, six other positive Phase 2 studies, and the functionality of the active arm in this study.
Priovant expects to announce the primary effects of the Phase 2 POC study of brepocitinib in the treatment of non-infectious uveitis (UNU) in the first quarter of 2024 and the primary effects of the Phase 3 trial in dermatomyositis (DM). in calendar year 2025.
BASEL, Switzerland, LONDON and NEW YORK, Nov. 27, 2023 (GLOBE NEWSWIRE) — Roivant (Nasdaq: ROIV) and Priovant announced that the Phase 2 study comparing oral brepocitinib in adult patients with moderate-to-severe active lupus failing to reach its number one endpoint is a four-fold increase in systemic lupus erythematosus (SRI-4) reaction rate at week 52. Privant plans to release data from the study at a later date.
“We saw some of the highest response rates to SRI-4 ever seen in a lupus study in the active arm of this trial, as well as a favorable protection and tolerability profile. Unfortunately, we also looked at the highest placebo reaction rate seen in any significant study in SLE and therefore it was not possible to truly assess the effect of the drug, nor to identify sufficient differentiation compared to other treatments in lupus patients. Although we do not plan to advance the program in SLE, those effects continue to support our view that oral brepocitinib is a highly active agent with an intelligent protection profile, and we remain excited about the potential for brepocitinib to produce significant clinical advantages in the Remedy for Noninfectious Uveitis. and dermatomyositis in ongoing trials of Priovant, as well as many other potential indications,” said Matt Gline, CEO of Roivant. “Roivant and Priovant would like to express our gratitude to the patients who participated in this trial, their caregivers, and the trial investigators who made this study and these data possible. »
Priovant expects to announce topline results from its own 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.
About Roivant
Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the progression and commercialization of essential medicines. Today, Roivant’s product portfolio includes VTAMA®, a new topical approved for the treatment of psoriasis and under development for the treatment of atopic psoriasis. dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRN”) progressing in various IgG-mediated autoimmune indications; brepocitinib, a novel late-stage TYK2/JAK1 inhibitor for dermatomyositis and other autoimmune diseases, as well as other clinical-stage molecules. We advanced our portfolio by creating agile subsidiaries or “Vants” to expand and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates early-stage corporations and fitness generation startups that complement its biopharmaceutical business. For more information, www. roivant. com.
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