Bristol-Myers Squibb (BMS) has partnered with Lupus Research Alliance and Lupus Therapeutics to evaluate a new investigational therapy, BMS-986165, for lupus erythematosus.
Lupus is a chronic autoimmune disease where the immune system generates antibodies that attack various organs such as kidneys, brain, heart, lungs, blood, skin and joints.
BMS-986165 is a potent and selective tyrosine kinase 2 inhibitor being developed to suppress pathways implicated in lupus.
The companies will assess the drug candidate in approximately 360 subjects during a global, multi-centre, randomised, placebo-controlled, double-blind Phase II clinical trial.
Expected to be completed in 2020, the trial will compare the safety and efficacy of orally administered BMS-986165 with placebo.
The primary outcome of the trial is the proportion of patients that meet response criteria for SLE Responder Index.
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By GlobalDataBMS development team lead John Throup said: “Early results to date indicate that BMS-986165 may be a promising oral therapy for people with lupus.
“Lupus Therapeutics has assembled a Network of world class investigators that are well-positioned to help us assess the potential of BMS-986165 in this disease.”
BMS will fund the trial and work with Lupus Therapeutics to identify sites within the Lupus Clinical Investigators Network (LuCIN) in the US to participate in the trial.
LuCIN has been established for fast and cost-effective testing of potential new drugs and approaches to diagnose and monitor response to therapy.