Lupus Research Alliance, Bristol-Myers Join to Advance Phase 2 Study of Oral Treatment for Lupus Nephritis

The Lupus Research Alliance (LRA) and its affiliate Lupus Therapeutics have expanded a collaboration with Bristol-Myers Squibb to help assess the company’s investigational agent BMS-986165 as a possible treatment for lupus nephritis.

The candidate’s effectiveness and safety will be evaluated in a global Phase 2 trial (NCT03943147) getting underway in more than 100 clinical sites, including those in the U.S. and Europe. More information is available here.

Aiming to enroll up to 78 people with lupus nephritis — a type of kidney inflammation caused by lupus — the trial will examine two oral doses of BMS-986165 versus a placebo, given in combination with standard-of-care treatment.

Its primary goals are to assess safety — defined as the incidence of adverse events and laboratory abnormalities — at 73 weeks of treatment, and the proportion of patients achieving a partial improvement in kidney symptoms at 24 weeks.

Secondary endpoints include the percentage of patients achieving complete renal responses, and those with complete responses and a reduced need for corticosteroid treatment. These goals will be evaluated at 24 and 52 weeks of treatment.

“Lupus nephritis is one of the most debilitating manifestations of systemic lupus, with approximately 10% of patients progressing to end stage renal disease,” John Throup, development team leader at Bristol-Myers Squibb, said in a press release. “New therapies are urgently needed and, with its network of investigators, Lupus Therapeutics is well positioned to help us assess the potential of BMS-986165 in this disease.”

The new study is an extension of a similar collaboration aimed at testing BMS-986165 as a potential therapy for systemic lupus erythematosus (SLE) patients.

The ongoing PAISLEY Phase 2 trial (NCT03252587), currently recruiting participants, is assessing three doses of BMS-986165 versus a placebo. Its main goal is to measure the proportion of SLE patients who respond to treatment, assessed by the SLE Responder Index (SRI).

Efficacy also will be assessed with other measures of disease activity, including the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), 40-Joint Count, and the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA).

BMS-986165 selectivity inhibits the tyrosine kinase 2 (TYK2) enzyme, which is involved in multiple autoimmune diseases, including lupus. BMS-986165 is the first therapy of its kind to be assessed in lupus.

“We are very excited to work with BMS [Bristol-Myers Squibb] on two important studies looking at a potential therapy for lupus and lupus nephritis,” Albert Roy, executive director of Lupus Therapeutics, said in the release.

“If interested in an opportunity to take part in clinical research, patients should speak with their physicians about what is involved and whether either of these studies may be right for them,” Roy added.

“We are delighted to expand our collaboration with Lupus Therapeutics to include both systemic lupus erythematosus and lupus nephritis,” Throup added.