Eliem Announces Updated Development Plans For Its Delayed Depression Candidate

In April, Eliem Therapeutics Inc ELYM delayed ETX-155 into Phase 2a depression trials to determine the root cause of a lower-than-expected exposure observed in a Phase 1b study in photosensitive epilepsy (PSE).
Based on an initial review, Eliem believes that the reduced exposure levels were most likely related to certain aspects of the chemistry, manufacturing, and controls for the different batches of the drug product.
The company plans to initiate a Phase 1 trial in healthy subjects using the drug batches used in the Phase 1b PSE trial to identify the dose required to provide similar exposure to the 60-milligram dose.
Related: See Here Why Recently Listed Eliem Therapeutics Shares Are Plummeting.
Results are expected in Q4 of 2022, and the subsequent Phase 2a trial in major depressive disorder will initiate in Q1 of 2023. Topline data are expected in mid-2024.
The company is postponing the planned Phase 2a trial in PMD. It will consider resuming the PSE trial after the expected readout of Phase 1 pharmacokinetic trial in Q4 of 2022.
The cash balance of $149.9 million is sufficient to fund key pipeline catalysts and operations until mid-2024.
Price Action: ELYM shares closed at $3.57 on Friday.