- Eliem Therapeutics Inc ELYM announced interim results from its ongoing Phase 1 trial of ETX-155 for major depressive disorder (MDD) and epilepsy.
- Following lower-than-expected drug exposure levels in the three subjects in a Phase 1b photosensitive epilepsy (PSE) trial, Eliem initiated a Phase 1 trial in healthy subjects to confirm the pharmacokinetic profile of ETX-155.
- ETX-155 demonstrates exposures in single dose 60-milligram cohorts of ongoing Phase 1 pharmacokinetic trial consistent with prior trials.
- Also see: Eliem Therapeutics Shares Fall On Lower Back Pain Trial Setback.
- Eliem plans to evaluate a 75-milligram dose of ETX-155 in the repeat dose part of the ongoing Phase 1 pharmacokinetic trial in healthy subjects.
- Final results, including the repeat dose cohort, are expected in Q4 of 2022.
- The company plans to start the Phase 2a MDD trial in Q1 of 2023, with the topline data expected in mid-2024.
- The company also said it will not reinitiate the PSE proof-of-concept trial but will continue to pursue the development of ETX-155 in focal onset seizures.
- The company is progressing two preclinical candidates from the Kv7.2/3 channel opener program for IND-enabling safety studies, expected in Q1 of 2023, with Phase 1 studies expected to start in 1H of 2024.
- The company has discontinued the preclinical development of a non-sedating anxiolytic for generalized anxiety disorder because none of the compounds achieved the required profile.
- The company ended the September quarter with a cash balance of $129.8 million, expected to fund operations into 2025.
- Price Action: ELYM shares are trading lower by 1.97% at $2.98 on the last check Wednesday.
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