Oral brepocitinib fails to meet primary endpoint in phase 2 lupus study
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Key takeaways:
- Brepocitinib failed to achieve an SRI-4 change of 4 at week 52 in adults with lupus
- The manufacturer plans to continue with the drug’s program outside of lupus, citing promising results in other trials.
Oral brepocitinib failed to meet its primary endpoint in a phase 2 trial of adults with moderate to severe lupus, according to a press release from the manufacturer.
The study aimed to assess brepocitinib (Priovant Therapeutics) based on the primary endpoint of Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4) at week 52. In a statement, Priovant, which holds the drug’s global development rights as well as its U.S. and Japan commercial rights, said it will disclose the full trial data at a later 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,” Matt Gline, CEO of Roivant, brepocitinib’s manufacturer, said in the release. “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.
Brepocitinib is a Janus kinase inhibitor with selectivity for tyrosine kinase 2 (TYK2) and JAK1 over JAK2 and JAK3. It has previously demonstrated promising data in reducing signs and symptoms of psoriatic arthritis through 52 weeks.
According to the release, Priovant plans to continue progressing the brepocitinib program outside of SLE, citing the drug’s favorable safety and tolerability profile, as well as data from six other phase 2 studies. The company said it expects to release topline data from a phase 2 study of brepocitinib in patients with non-infectious uveitis sometime in the first quarter of 2024. Additional data from a phase 3 trial in dermatomyositis are expected in 2025.
According to the company, oral brepocitinib has demonstrated statistically significant, clinically meaningful benefits across six completed placebo-controlled phase 2 studies in psoriasis, PsA, alopecia areata, hidradenitis suppurativa, ulcerative colitis and Crohn’s disease.
“While we do not plan to progress the program in SLE, these results continue to support our view that oral brepocitinib is a highly active agent with a good safety profile, and we remain enthusiastic about brepocitinib’s ability to produce meaningful clinical benefit in non-infectious uveitis and dermatomyositis in Priovant’s ongoing trials, as well as in many other potential indications,” Gline said in the release.
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