Eliem Therapeutics, Inc. reported results from its Phase 2a clinical trial investigating ETX-810 for the treatment of lumbosacral radicular pain (LSRP). ETX-810 is a novel, new chemical entity prodrug of the bioactive lipid palmitoylethanolamide that was evaluated in two Phase 2a clinical trials, one in subjects with diabetic peripheral neuropathic pain (DPNP) and one in subjects with LSRP, commonly referred to as sciatica. In the Phase 2a clinical trial in LSRP, ETX-810 did not achieve statistically significant separation from placebo on the trial's primary endpoint, which assessed the change from baseline to week 4 in the weekly average of the daily pain score measured with the Pain Intensity Numerical Rating Scale (PI-NRS).

This result is consistent with the lack of separation from placebo observed in the Phase 2a clinical trial in DPNP, as reported in April 2022. Therefore, the Company has elected to discontinue further development of ETX-810. The Company recently provided an update that its capital is sufficient to fund key pipeline catalysts and operations until mid-2024.

With the discontinuation of ETX-810, the Company anticipates that its cash runway will extend beyond that time and expects to provide more detail on the extended cash runway in connection with its second quarter 2022 financial results release. The multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial (NCT04778592) evaluated the efficacy and safety of ETX-810 in 148 subjects with LSRP over four weeks of dosing. Patients were randomized 1:1 to 1,000 mg of ETX-810 twice daily or placebo.

ETX-810 was well tolerated in the study, with a safety profile consistent with previous studies. However, the primary endpoint of the study was not achieved, and separation from placebo on the PI-NRS was not observed during the four weeks of dosing.