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eliem Therapeutics Eliem Therapeutics Reports Third Quarter Financial and Business Highlights November 8 , 2021 Advanced ETX - 155 clinical development program , with the first subject successfully screened in epilepsy proof - of - concept trial and significant progress made toward the initiation of major depressive disorder ( MDD ) and perimenopausal depression ( PMD ) clinical trials Continued to enroll ETX - 810's two Phase 2a chronic pain clinical trials , with topline data anticipated in the first half of 2022 On track to progress Kv7.2 / 3 channel opener program into Investigational New Drug ( IND ) -enabling studies in the first half of 2022 SEATTLE and CAMBRIDGE , United Kingdom , Nov. 08 , 2021 ( 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 in chronic pain , psychiatry , epilepsy and other disorders of the peripheral and central nervous systems , today reported financial results and business highlights for the quarter ended September 30 , 2021 . " Our clinical execution is progressing well , " said Bob Azelby , Eliem's president and chief executive officer . " For ETX - 155 , we are excited to report that we have completed our Phase 1 studies , we have successfully screened our first patient in our photosensitive epilepsy ( PSE ) proof - of - concept clinical trial and we continue to progress clinical development activities for the launch of our phase 2a trials evaluating ETX - 155 in patients with MDD and PMD . As we look to expand our clinical pipeline , we are increasingly excited about the potential of our Kv7.2 / 3 channel opener program as a clinically validated mechanistic approach to treat diseases such as epilepsy , pain and MDD , and we remain on track to progress the program into IND - enabling studies in the first half of 2022. " Third Quarter 2021 Highlights and Recent Developments Completed 14 - day repeat dose Phase 1 study demonstrating ETX - 155 was well tolerated with an approximate 40 - hour half - life supporting once - daily dosing . The 14 - day , repeat dose , Phase 1 study evaluated the pharmacokinetic profile and safety of ETX - 155 in 20 healthy human subjects , evaluating 60 mg ETX - 155 ( n = 15 ) or placebo ( n = 5 ) dosed daily in the evening for 14 days . Results demonstrated ETX - 155 reached steady state concentration at Day 8 and had an approximate 40 - hour half - life , confirming ETX - 155's desirable profile for a once - daily dosing regimen . The study also confirmed that ETX - 155 was generally well tolerated with no severe or serious adverse events , or discontinuations . All treatment - emergent adverse events ( TEAEs ) , including central nervous system ( CNS ) adverse events , were mild / moderate and transient . In particular , all somnolence adverse events were mild and the incidence was comparable in the ETX - 155 and placebo groups . Notably , somnolence events were sporadic , and no subject who reported somnolence in either the ETX - 155 or placebo arms reported it more than once during the dosing or follow - up period . In addition , there was no clinically meaningful difference compared to placebo in sleep quality or next morning state of arousal , as measured by the Leeds Sleep Evaluation Questionnaire . The tolerability and safety findings of this study were consistent with those of the previous 7 - day repeat dose and single ascending dose Phase 1 study . Collectively , the Company's Phase 1 studies have demonstrated that ETX - 155 has differentiated pharmacokinetic properties , including no clinically meaningful food effect and an approximate 40 - hour half - life to enable a once - daily dosing regimen . Screened the first subject in ETX - 155 photosensitive epilepsy clinical trial : The Company anticipates dosing the first subject in the single - arm proof - of - concept Phase 1b PSE trial by the end of 2021. Precedent literature demonstrates that activity in single - dose PSE trials can be a reliable predictor of anticonvulsant activity in various forms of epilepsy , such as focal onset seizure . Advanced study start - up activities for ETX - 155 Phase 2a clinical trials in MDD and PMD : The Company anticipates dosing the first subject in each of these studies in early 2022 , assuming regulatory approval of its IND application . Program Updates and Anticipated Milestones ETX - 810 in chronic pain : ETX - 810 is a novel new chemical entity prodrug of the bioactive lipid palmitoylethanolamide that is currently being evaluated in two Phase 2a clinical trials in subjects with diabetic peripheral neuropathic pain ( DPNP ) and lumbosacral radicular pain ( LSRP ) , commonly referred to as sciatica . • ETX - 810 in DPNP . The ongoing Phase 2a prospective , multi - center , randomized , double - blind , placebo - controlled , parallel - group clinical trial evaluating the efficacy and safety of ETX - 810 in subjects with DPNP remains on track to have topline data readout during the first half of 2022 . • ETX - 810 in LSRP . The ongoing Phase 2a prospective , multi - center , randomized , double - blind , placebo - controlled , parallel - group clinical trial evaluating the efficacy and safety of ETX - 810 in subjects with LSRP remains on track to have topline data readout during the first half of 2022 . ETX - 155 in depression and epilepsy : ETX - 155 is a novel GABAA receptor positive allosteric modulator ( PAM ) that Eliem plans to evaluate in subjects with MDD , PMD and focal onset seizure ( FOS ) . • ETX - 155 in FOS . The Company expects to report topline data from its ongoing single - arm , proof - of - concept Phase 1b trial