XTL Biopharmaceuticals has completed the design of a Phase 2 clinical trial investigating its drug candidate hCDR1 for systemic lupus erythematosus (SLE). The planned international study will be launched this year after the company files its investigational new drug (IND) paperwork with the U.S. FDA.
XTL’s lead product hCDR1 is a disease-specific drug that targets autoimmune processes by generating regulatory T-cells. These cells can initiate immune signaling cascades that act on active B- and T-cells, autoantibodies, cytokines, and other immune molecules that contribute to lupus pathology. These changes are believed to induce a balance in the disturbed immune system of lupus patients.
Earlier clinical studies in about 400 patients have shown that the drug has a good safety profile, and preliminary data indicated it was effective in at least one clinically meaningful endpoint.
The planned Phase 2 study was designed in consultation with XTL’s clinical advisory board after XTL received positive feedback from the FDA during pre-IND meetings.
The study will be a 26-week, double-blind, placebo-controlled trial that aims to explore the safety and efficacy of hCDR1. It will compare two different doses of the drug with placebo, evaluating the proportion of patients that achieve a beneficial response in at least one organ system after 26 weeks of treatment.
Secondary endpoints of the study will include a response on the BILAG index – a standard diagnostic measure of lupus severity in different organ systems – and other evaluative tools accepted by the FDA.
“We worked closely with the world-renowned lupus experts on our Clinical Advisory Board to develop this study design based on the BILAG index as a measure of hCDR1’s efficacy,” Josh Levine, XTL’s CEO, said in a press release.
“The FDA’s recent guidance indicating that BILAG is an appropriate efficacy endpoint for our trial was a very significant and positive milestone. It enabled us to optimize our study design, and in our opinion, improves the likelihood of the study’s success based on the efficacy results of the prior Phase 2 trial when a 0.5 mg dose of hCDR1 was used with the BILAG index,” Levine said. “We look forward to filing our IND in the U.S. and commencing the trial this year.”