Eliem Therapeutics Outlines Interim Data From Early-Stage Depressive Study

  • 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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