Eliem Therapeutics, Inc. (Nasdaq: ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in psychiatry, epilepsy, chronic pain, and other disorders of the peripheral and central nervous systems, today provided a business update and reported financial results for the quarter ended June 30, 2022.
“We continue to advance our pipeline targeting neuronal excitability disorders,” said Bob Azelby, president and chief executive officer of Eliem Therapeutics. “While we are disappointed with our recent announcement regarding the discontinuation of ETX-810, we continue to actively progress ETX-155. We have initiated our previously announced Phase 1 pharmacokinetic study of ETX-155 that is intended to confirm the dose that we will advance into a Phase 2a clinical trial in patients with major depressive disorder (MDD). We are encouraged by the precedent validation of the GABAA PAM class in multiple large depression trials and believe ETX-155 has the potential to be a clinically differentiated GABAA PAM product candidate.”
ETX-810 in chronic pain: ETX-810 is a novel, new chemical entity prodrug of the bioactive lipid palmitoylethanolamide (PEA). On August 2, 2022, the Company reported that ETX-810 did not achieve statistically significant separation from placebo on the primary endpoint in the Phase 2a clinical trial investigating ETX-810 for the treatment of lumbosacral radicular pain. This result is consistent with the lack of separation from placebo observed in the Phase 2a clinical trial in diabetic peripheral neuropathic pain, as reported in April 2022. Therefore, the Company has discontinued further development of ETX-810.
ETX-155 in depression and epilepsy: ETX-155 is a novel GABAA receptor positive allosteric modulator that the Company plans to evaluate in subjects with major depressive disorder (MDD) and epilepsy. In July 2022, the Company initiated a Phase 1 pharmacokinetic trial in healthy subjects using the drug batches that were used in the Phase 1b photosensitive epilepsy (PSE) trial. The objective of this Phase 1 trial is to identify the dose required to provide similar exposure to that of the 60-milligram dose used in the previous 14-day repeat dose Phase 1 healthy volunteer trial. Results from the Phase 1 pharmacokinetic trial are expected in the fourth quarter of 2022. Once a dose level with appropriate exposure and safety is confirmed, the Company intends to initiate its previously planned randomized, placebo-controlled Phase 2a clinical trial in MDD patients. Assuming success in Phase 1 pharmacokinetic trial in healthy subjects, the Company anticipates initiating this Phase 2a trial in MDD in the first quarter of 2023, and topline data would be expected in mid-2024. The Company will consider resuming the PSE trial after the expected readout of Phase 1 pharmacokinetic trial in the fourth quarter of 2022.
Kv7.2/3 channel opener program: The Company’s preclinical program targets the Kv7.2/3 potassium channel, a target that has clinical validation in pain and epilepsy. The Company has filed foundational intellectual property claims on its novel Kv7 development candidate and remains on track to initiate IND-enabling studies in 2022.
Anxiolytic for generalized anxiety disorder (GAD): The Company is in early preclinical development of a novel, rapid-acting, non-sedating, non-addictive anxiolytic for the potential treatment of GAD. The Company is continuing the preclinical development of this program with the intent to provide a development plan update later in 2022.
