Beeline Medicines has announced that its global Phase II clinical trial involving adults with active moderate-to-severe systemic lupus erythematosus (SLE), evaluating afimetoran, achieved the primary endpoint.
The trial showed that all three doses of afimetoran resulted in higher SLE Responder Index-4 (SRI-4) response rates at week 48 compared with placebo, with a p-value of less than 0.001 across all dose groups.
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Secondary endpoints showed improvements consistent with those observed in the primary endpoint.
Participants received once-daily oral afimetoran or placebo alongside standard background therapies, including corticosteroids.
The randomised, double-blind, placebo-controlled and dose-ranging trial enrolled 248 adults aged 18 to 70 years, all of whom had active moderate-to-severe SLE despite background treatment.
Secondary outcomes in the study included disease activity, manifestations in skin and joints, corticosteroid reduction, physician global assessment, and quality of life measures.
Safety and tolerability results indicated afimetoran was generally well tolerated and had a safety profile in line with findings from a previous Phase I study.
No new safety signals were observed during the trial period. Further details from the study will be made available at an upcoming medical congress.
Beeline Medicines CEO Saqib Islam said: “Too many people with systemic lupus continue to cycle through therapies that do not adequately control their disease, leaving them with diminished quality of life and vulnerable to debilitating long-term complications.
“These positive Phase II results strengthen our conviction that afimetoran has the potential to meaningfully change the treatment landscape as a foundational oral therapy for lupus patients.
“We look forward to advancing our programme into pivotal development for those who urgently need new options.”
Afimetoran, a selective oral inhibitor of Toll-like receptors 7 and 8, was discovered by researchers at Bristol Myers Squibb and licensed to Beeline Medicines in July 2025.
It previously demonstrated exploratory efficacy in a Phase Ib study in cutaneous lupus erythematosus and received fast track designation from the US Food and Drug Administration for SLE in May 2025.
