Initiation of a Phase 1 pharmacokinetic trial of ETX-155 to enable a Phase 2a trial in MDD expected to begin in the first quarter of 2023
Sufficient capital should fund operations until mid-2024
SEATTLE and CAMBRIDGE, UK, July 18 12, 2022 (GLOBE NEWSWIRE) — Eliem Therapeutics, Inc. (Nasdaq: ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs for chronic pain, psychiatry, epilepsy and other peripheral and central nervous system disorders, today provided an update on its plans to advance its ETX-155 clinical program.
ETX-155 is a new neuroactive GABA steroidA positive allosteric receptor modulator (PAM) that the Company plans to evaluate in subjects with major depressive disorder (MDD), perimenopausal depression (PMD) and epilepsy. In April 2022, the company elected to delay advancing ETX-155 into phase 2a depression trials to determine the root cause of lower than expected exposure seen in a proof-of-concept trial. phase 1b of ETX-155 in photosensitive epilepsy (PSE). Based on an initial review of ongoing analyses, the Company believes that the reduced exposure levels were most likely related to certain aspects of chemistry, manufacturing and controls (CMC) for the different batches of drug products. used in Phase 1 trials on healthy volunteers. and the Phase 1b PSE trial. The evaluation and implementation of changes to the CMC process to ensure consistency in the manufacturing of pharmaceutical products is currently underway. In parallel, the Company plans to initiate a Phase 1 pharmacokinetic trial in healthy subjects using the drug batches that were used in the Phase 1b PSE trial. The goal of this Phase 1 trial is to identify the dose needed to provide similar exposure to the 60 milligram dose used in the previous Phase 1 trial in healthy volunteers at 14-day repeat doses. Once a dose level with appropriate exposure and safety is confirmed, the company intends to initiate its previously planned Phase 2a trial of ETX-155 in patients with MDD.
Results from the Phase 1 pharmacokinetic trial are expected in Q4 2022, and the subsequent randomized, placebo-controlled Phase 2a trial in patients with MDD is expected to commence in Q1 2023. This Phase 2a trial is expected to be a proof-of-concept study with 4-week treatment, with subjects randomized 1:1 to receive ETX-155 or placebo, assessing efficacy parameters from Day 3 to Day 42. Assuming start of MDD trial phase 2a in the first quarter of 2023, the main data from this trial would be expected in mid-2024.
The company is postponing the start of the planned Phase 2a trial in PMD, which will provide additional investment flexibility for Eliem’s pipeline progression. The Company will consider resuming the PSE trial following the planned Phase 1 pharmacokinetic trial readout in Q4 2022.
In addition to ETX-155, the company expects to release leading data for its clinical candidate, ETX-810, in lumbosacral radicular pain (LSRP) in the third quarter of 2022 and is advancing a new research program. opening of the Kv7 channel which should begin Studies allowing the IND in the second half of 2022.
“We look forward to getting our ETX-155 program back into the clinic and believe this new plan takes CMC off the critical path and provides an effective way to effectively advance the drug into the Phase 2a MDD trial,” said Bob Azelby, President of Eliem. and CEO. “We are encouraged by the previous validation of GABAA PAM class in several large depression trials and believe ETX-155 has potential to be a clinically differentiated GABAA PAM product candidate. We also look forward to publishing our first results for ETX-810 in LSRP, an indication for which there is prior randomized, placebo-controlled clinical data for PEA dietary supplement formulations supporting the mechanism of action of ETX-810. ETX-810. With our strong cash position of $149.9 million at the end of the first quarter of 2022, we believe we have sufficient capital to fund catalysts and key pipeline operations through mid-2024. »
About Eliem Therapeutics
Eliem Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems. These disorders often arise when neurons are over-excited or inhibited, leading to an imbalance, and our goal is to restore homeostasis. We are developing a pipeline of clinically differentiated product candidates focused on validated mechanisms of action with broad therapeutic potential to provide improved treatments for patients with these disorders. Eliem channels his experience, energy and passion for improving patients’ quality of life to fuel our efforts to develop new, life-changing therapies. At its core, the Eliem team is driven by the promise of helping patients live happier, more fulfilling lives. Learn more at https://eliemtx.com/ or follow us on LinkedIn.
This press release contains forward-looking statements, including, but not limited to, statements regarding: the continued development and clinical and therapeutic potential of ETX-155, ETX-810 and the initiation program Eliem’s Kv7 channel; Eliem’s belief regarding the likely cause of lower than expected exposure observed in the referenced Phase 1b proof-of-concept trial of ETX-155 in the PSE; Eliem’s plans and activities relating to changes to the ETX-155 CMC process; Eliem’s plans to initiate a Phase 1 pharmacokinetic trial of ETX-155 and the timing thereof, the purpose of such trial and the expected availability of key data; Eliem’s plans to initiate its previously planned Phase 2a trial of ETX-155 in patients with MDD and the timing thereof; the expected availability of front-line data for Eliem’s ETX-810 Phase 2a trial in the LSRP and the timing thereof; the progress of the Kv7 channel opening program; the belief that Eliem has sufficient capital to fund major pipeline catalysts and operations through mid-2024; and Eliem’s commitment to developing therapies targeting debilitating disorders. Words such as “advance”, “anticipate”, “believe”, “differentiate”, “effective”, “allow”, “encourage”, “expect”, “focus”, “initiate”, “have intention”, “investment”, “probable”, “looking forward”, “goal”, “potential”, “progress”, “sufficient”, “will”, “would” or other similar expressions, identify forward-looking statements , but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements contained in this press release are based on Eliem’s current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the schedule of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, but are not limited to: the clinical, therapeutic and commercial value of the ‘ETX-810, ETX-155 and Eliem’s preclinical programs; risks related to the potential failure of ETX-810 and ETX-155 to demonstrate safety and efficacy in clinical trials; Eliem’s ability to initiate and conduct clinical trials and studies of ETX-810 and ETX-155 sufficient to obtain a positive conclusion; availability of data at scheduled times; Eliem’s ability to obtain and protect intellectual property rights, and to operate without infringing the intellectual property rights of others; the uncertain timing and level of expenditures associated with Eliem’s preclinical and clinical development activities; the sufficiency of capital and other resources of Eliem; risks and uncertainties related to regulatory application, review and approval processes and Eliem’s compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; impacts on Eliem’s business due to external events, including health pandemics or other contagious epidemics, such as the current COVID-19 pandemic; and other factors discussed under “Risk Factors” in Eliem’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022. This filing is available on the SEC’s website at address www.sec.gov. Additional information will also be set forth in other reports and documents filed by Eliem with the SEC from time to time. Forward-looking statements made in this press release speak only as of the date of this press release. Eliem expressly disclaims any duty, obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained herein to reflect any change in Eliem’s expectations with respect thereto or any change in events, conditions or circumstances. on which these statements are based. .