Phase 1 Trial Testing Safety of Potential Lupus Therapy, LY3361237, Underway

A Phase 1 clinical trial evaluating Eli Lilly’s investigational therapy LY3361237 in healthy people has dosed its first participant, Sanford Burnham Prebys Medical Discovery Institute (SBP) announced.

The treatment is being developed for auto-immune conditions like lupus, psoriasis, and rheumatoid arthritis, where the immune system is overactive and attacks healthy cells and tissues. It is designed to inhibit inflammation by targeting and activating an immune checkpoint receptor, and so keep immune cells in check.

The Phase 1 trial (NCT03695198), sponsored by Eli Lilly, is expected to include 85 adults and to determine the safety of LY3361237. Participants will be randomly assigned the treatment candidate, or a placebo, given either under the skin (subcutaneously) or directly into the blood (intravenously).

Participants will remain at the the clinical research unit for four days after treatment.

In addition to determining LY3361237’s safety, which will be done by evaluating any adverse events associated with treatment, researchers also aim to measure the therapy’s pharmacokinetic profile, including how much reached the bloodstream and how long the body takes to excrete it.

“Today’s milestone is an important step forward for patients who suffer from autoimmune disease,” Carl Ware, PhD, director of the Infectious and Inflammatory Diseases Center at the La Jolla, California-based SBP, said in a press release.

“This advance also illustrates how the fundamental understanding of a biological process—in this case, the role of checkpoint receptors in immune function—can translate to the development of new medicines,” Ware added.

LY3361237 is the outcome of collaboration established in 2015 between Eli Lilly and Sanford-Burnham to developed novel immune-targeting therapies. The partnership joins Lilly’s biotechnology and expertise in immunology with the Sanford-Burnham’s knowledge on the pathways regulating the immune system, especially immune checkpoints.

“Immunological disorders — many of which disproportionately impact women — affect millions of people around the world and remain an area of great medical unmet need,” said Ajay Nirula, MD, PhD, vice president of Immunology at Lilly.