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Eliem Therapeutics Announces Last Patient Completed Dosing in Phase 2a Study of ETX-810 in Patients with Lumbosacral Radicular Pain

Topline data from the Phase 2a clinical trial are expected in the third quarter of 2022. Virtual investor event to be held in July 2022

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Eliem Therapeutics, 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, today announced that it has completed dosing of the last patient in its Phase 2a trial of ETX-810 in patients with chronic lumbosacral radicular pain (LSRP), a condition commonly referred to as sciatica.

ETX-810 is an investigational first-in-class, oral, non-opioid, new chemical entity (NCE) prodrug of the bioactive lipid palmitoylethanolamide (PEA). Topline data from the Phase 2a clinical trial are expected in the third quarter of 2022, and the Company plans to host a virtual investor event ahead of the data to discuss the opportunity for ETX-810 for the treatment of LSRP.

LSRP is a neuropathic pain syndrome caused by compression, inflammation and/or injury of spinal nerve roots in the lower back and is characterized by lower back pain that radiates into the leg. The leg pain is typically much worse than the lower back pain and is described as being electric, burning or sharp. Additionally, affected people may experience numbness, muscle weakness and loss of specific reflexes. It is estimated to affect approximately 10 million to 16 million people in the United States and 15 million to 26 million people in Europe.

“We are pleased to announce that we have dosed the last patient in our Phase 2a clinical trial evaluating ETX-810 in patients with LSRP,” said Bob Azelby, Eliem’s president and chief executive officer. “LSRP is a large, underserved market where a significant percentage of patients treated with standard of care are inadequately relieved of their pain. We are encouraged by the precedent published randomized, placebo-controlled trials of PEA dietary supplement formulations in this setting and we believe that ETX-810 has the potential to become a differentiated, well tolerated, non-opioid therapeutic option for the millions of patients globally suffering from LSRP if it receives regulatory approval.”

The ETX-810 trial in LSRP is a randomized, placebo-controlled, Phase 2a proof-of-concept trial with 149 LSRP patients enrolled at sites across the United States. The primary endpoint will evaluate the change from baseline to Week 4 in weekly average of the daily pain score rated on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS).

For additional clinical trial information, please refer to www.clinicaltrials.gov.

Eliem plans to host a virtual investor day in the third quarter to discuss the LSRP treatment landscape, the unmet clinical need in this indication, and ETX-810’s clinical program and potential commercial opportunity. The Company will announce details for the event when they are finalized, and a webcast of the event will be available on the Company’s website.

ETX-810 is a novel, non-opioid prodrug of palmitoylethanolamide (PEA), being developed for the treatment of patients suffering from lumbosacral radicular pain. PEA is an endogenous bioactive lipid known to broadly modulate neuroinflammation and pain signaling. PEA in dietary supplement formulations has been evaluated as a treatment for various pain conditions in more than 30 clinical studies, with over 2,500 patients treated with PEA in these studies.

Fifteen of these studies were randomized, controlled trials (RCTs) in a total of approximately 1,500 patients, where PEA consistently demonstrated statistically significant reductions in pain with favorable safety and tolerability. As a prodrug of PEA, ETX-810 was designed to significantly improve the absorption and systemic exposure of PEA to maximize the therapeutic effect. In addition to its potential as a novel approach to significantly reduce chronic pain, in clinical testing to date ETX-810 has demonstrated a very encouraging safety and tolerability profile.

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