Collaboration Advances Phase 2 Trial Testing Potential New Therapy for Lupus

The Lupus Research Alliance and its newly formed affiliate Lupus Therapeutics will collaborate with Bristol-Myers Squibb (BMS) to test a novel investigational candidate BMS-986165 as a potential therapy for lupus.

BMS-986165 is the first of its kind to be tested in lupus. The medicine is a potent, highly-selective inhibitor of Tyrosine kinase 2 (Tyk2) that suppresses pathways implicated in lupus.

The candidate’s effectiveness and safety will be evaluated in a Phase 2 global, multi-center clinical trial (NCT03252587) that recently started recruiting 400 participants with systemic lupus erythematosus (SLE) worldwide.

Primary outcome measures will be the number of participants who meet response criteria for SLE Responder Index 4 in 32 weeks.

Lupus Therapeutics and BMS will work together to identify sites in the U.S. within the Lupus Clinical Investigators Network (LuCIN) to be included in the global Phase 2 study. The network was created and is currently managed by Lupus Therapeutics to address the slow pace of developing new lupus therapies.

Recognizing there are limited therapeutic options for lupus patients, LuCIN was designed to provide a framework to quickly and cost-effectively test potential new therapeutic products, as well as methods to diagnose and monitor treatment response from patients.

“There remains a desperate need for effective treatments for lupus without the serious side effects common with existing options,” Albert Roy, executive director of Lupus Therapeutics, said in a press release. “BMS-986165 is a very interesting and promising intervention for patients living with lupus. We are very excited to be partnering with BMS on this trial that we hope advances another treatment option for the disease,” he 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. We are delighted to work with them as part of the phase 2 program to accelerate clinical development of potential therapies for lupus,” added John Throup, development team lead at BMS.

In November 2017, the Lupus Research Alliance launched the first clinical trials conducted through LuCIN.

This first portfolio of clinical studies included: a Phase 2 trial (NCT02975336) designed to evaluate evobrutinib (M2951) in lupus patients; a non-interventional clinical study (NCT03142711) evaluating if a custom smartphone app enabled lupus patients to report on their health-related quality of life and other symptoms in real time; a Phase 4 clinical trial (NCT03098823) designed to assess if Rayos (prednisone) was better than immediate-release prednisone at improving fatigue in lupus patients; a collaborative study (NCT03180021) investigating several kidney imaging modalities in the assessment of lupus nephritis; and a collaborative Phase 2 trial (NCT02185040) designed to assess CC-220 as a treatment for lupus.

LuCIN currently connects 59 academic research centers in several North American cities. More information about the network and its work is available here.