ETX-155 / Climb Bio - LARVOL DELTA

New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development. (PubMed, CNS Drugs) - "The first group consists of positive allosteric modulators of GABA receptors and includes Staccato alprazolam (an already marketed benzodiazepine being repurposed in epilepsy as a potential rescue inhalation treatment for prolonged and repetitive seizures), the α2/3/5 subtype-selective agents darigabat and ENX-101, and the orally active neurosteroids ETX155 and LPCN 2101...These include bumetanide, a diuretic agent that has undergone clinical trials in phenobarbital-resistant neonatal seizures and for which the rationale for further development in this indication is under debate, and ivermectin, an antiparasitic drug currently investigated in a randomised double-blind trial in focal epilepsy. The last group comprises a series of highly innovative therapies, namely GABAergic interneurons (NRTX-001) delivered via stereotactic cerebral implantation as a treatment for mesial temporal lobe epilepsy, an antisense oligonucleotide (STK-001) aimed at upregulating NaV1.1 currents..."

Journal • Review • CNS Disorders • Epilepsy • Gene Therapies

Eliem Therapeutics Provides Update on Pipeline Progress (Yahoo Finance) - "ETX-155 program: ETX-155 is a novel GABAA receptor positive allosteric modulator (GABAA PAM) that is being developed for the treatment of major depressive disorder (MDD) and epilepsy....Kv7.2/3 channel opener program: The Company’s preclinical program targets the Kv7.2/3 potassium channel (Kv7), a target that has clinical validation in pain and epilepsy....the initiation of IND-enabling safety studies, expected in the first quarter of 2023, with Phase 1 studies planned to initiate in the first half of 2024."

IND • New P1 trial • CNS Disorders • Epilepsy

Eliem Therapeutics Reports Second Quarter Financial and Business Highlights (GlobeNewswire) - "Initiated Phase 1 pharmacokinetic trial for ETX-155 with expected results in Q4 2022....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....Results from the Phase 1 pharmacokinetic trial are expected in the fourth quarter of 2022....Assuming success in the Phase 1 pharmacokinetic trial in healthy subjects....The Company will consider resuming the PSE trial after the expected readout of the Phase 1 pharmacokinetic trial in the fourth quarter of 2022."

P1 data • CNS Disorders • Epilepsy

"$ELYM Eliem Announces Updated Development Plans and the Advancement of ETX-155 for the Treatment of Major Depressive Disorder https://t.co/UvULHPt27Q" (@stock_titan)

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

"$ELYM Eliem Provides Update on ETX-810 and ETX-155 Clinical Programs https://t.co/P8JJF3V3Mg" (@stock_titan)

Clinical

The imidazodiazepine, KRM-II-81: An example of a newly emerging generation of GABAkines for neurological and psychiatric disorders. (PubMed, Pharmacol Biochem Behav) - "Recently, however, there has been a resurgence of efforts to bring GABAkines to patients, the FDA approval of the neuroactive steroid brexanolone for post-partum depression in 2019 being the first. Other neuroactive steroids are in various stages of clinical development (ganaxolone, zuranolone, LYT-300, Sage-324, PRAX 114, and ETX-155). These GABAkines and non-steroid compounds (GRX-917, a TSPO binding site ligand), darigabat (CVL-865), an α2/3/5-preferring GABAkine, SAN711, an α3-preferring GABAkine, and the α2/3-preferring GABAkine, KRM-II-81, bring new therapeutic promise to this highly utilized medicinal target in neurology and psychiatry...KRM-II-81 also produces anxiolytic- and antidepressant-like effects in rodent models. Other key features of the pharmacology of this compound are its low sedation rate, lack of tolerance development, and the ability to prevent the development of seizure sensitization."

Journal • Review • Anesthesia • CNS Disorders • Depression • Epilepsy • Mental Retardation • Neuralgia • Pain • Postpartum Depression • Psychiatry • Vascular Neurology

Eliem Therapeutics Provides Program Updates and an Overview of Expected Near-Term Milestones (GlobeNewswire) - "Eliem Therapeutics, Inc...today is providing program updates and announcing expected milestones....Achieved full enrollment in the 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. The Company expects topline data in the first half of 2022....Enrollment is ongoing for the 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. The Company expects enrollment to be completed in the first half of 2022 and now expects topline data in the second half of 2022....ETX-155 in epilepsy. Enrollment is ongoing for the single-arm Phase 1b trial in subjects with photosensitive epilepsy (PSE), a single dose proof-of-concept study for epilepsy. The Company expects interim data in the first half of 2022."

Enrollment closed • Enrollment status • P1 data • P2a data • Back Pain • CNS Disorders • Epilepsy • Lumbar Back Pain • Pain • Peripheral Neuropathic Pain

Eliem Therapeutics Reports Third Quarter Financial and Business Highlights (GlobeNewswire) - "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."

New P1 trial • CNS Disorders • Epilepsy

Eliem Therapeutics Reports Second Quarter Financial Results (GlobeNewswire) - P1, N=NA; "In Phase 1 clinical studies to date, ETX-155 was shown to be well tolerated with desirable pharmacokinetic properties, including no clinically meaningful food effect and at least a 24-hour half-life to enable once-a-day-dosing....ETX-155 in MDD: The Company expects to initiate a randomized, placebo-controlled, Phase 2a proof-of-concept trial of ETX-155 in the second half of 2021 with first patient dosed in early 2022 and topline data expected in the first half of 2023. ETX-155 in PMD: The Company expects to initiate a randomized, placebo-controlled, Phase 2a proof-of-concept trial of ETX-155 in the second half of 2021 with first patient dosed in early 2022 and topline data expected in the first half of 2023....Anxiolytic for generalized anxiety disorder (GAD): The Company is also in early preclinical development of a novel, rapid-acting, non-sedating, non-addictive anxiolytic for the potential treatment of GAD. The Company plans to nominate a clinical candidate in 2022."

New molecule • New P2a trial • P1 data • P2 data • Preclinical • CNS Disorders • Depression • Major Depressive Disorder

Eliem Therapeutics Reports Second Quarter Financial Results (GlobeNewswire) - "Program Updates and Milestones...ETX-155 in FOS. The Company expects to initiate a single-arm, proof-of-concept Phase 1b trial in photosensitive epilepsy patients in the second half of 2021 with topline data expected by the first half of 2022."

New P1 trial • P1 data • CNS Disorders • Epilepsy

Eliem Therapeutics’ NASDAQ IPO raises $92 million (Business Weekly) - "Less than six months after emerging from stealth, Cambridge UK and Seattle-based BioMedTech business Eliem Therapeutics, Inc has raised $92 million through an oversubscribed NASDAQ IPO....Eliem is in the process of advancing its two lead clinical-stage product candidates, ETX-810 and ETX-155, through topline data across four different indications in patients with chronic pain, depressive disorders and epilepsy – as well as to advance its two preclinical-stage programs to selection of clinical development candidates."

Financing • CNS Disorders • Depression • Epilepsy • Major Depressive Disorder • Pain

Nervous system biotech Eliem Therapeutics lowers deal size by 7% ahead of $75 million IPO (Renaissance Capital) - "Eliem Therapeutics...lowered the proposed deal size for its upcoming IPO on Monday. The Redmond, WA-based company now plans to raise $75 million by offering 6 million shares at $12.50....The company plans to initiate two Phase 2a trials for ETX-155 in patients with MDD and PMD which are expected to report topline data in the 1H23."

Financing • P2a data • CNS Disorders • Depression • Major Depressive Disorder

Nervous System Firm Eliem Therapeutics Files For $80M IPO (Benzinga) - "Eliem Therapeutics...filed an IPO prospectus with the SEC to raise up to $80 million....ETX-810 is currently in two Phase IIa studies looking at diabetic peripheral neuropathic pain and lumbosacral radicular pain....ETX-155 is a GABA-positive allosteric modulator...Researchers plan to take this program into two Phase IIa studies for major depressive disorder and hormone-related depressive disorders, as well as a Phase Ib trial for epilepsy."

Financing • Back Pain • CNS Disorders • Depression • Epilepsy • Major Depressive Disorder • Pain • Peripheral Neuropathic Pain

Eliem Therapeutics Announces $60 Million Series B Financing (PRNewswire) - "Eliem Therapeutics...announced the closing of a $60 million Series B financing....Eliem plans to use the proceeds to advance its two lead clinical-stage product candidates, ETX-810 and ETX-155...For its second lead product candidate, ETX-155, an investigational novel GABAA receptor positive allosteric modulator, Eliem plans to initiate two Phase 2a clinical trials, in patients with major depressive disorder and hormone-related depressive disorders, which are expected to report topline data in the second half of 2022 and the first half of 2023, respectively."

Financing • New P2a trial • P2a data • Depression • Major Depressive Disorder

Eliem Therapeutics Series B takes fundraising haul to $140 million (Business Weekly) - "Cambridge UK and Seattle biotech company Eliem Therapeutics has raised $60 million Series B financing – taking its haul to date to $140m. Eliem is developing novel therapies for neuronal excitability disorders...ETX-155, Eliem intends to initiate a Phase 1b clinical trial in patients with photosensitive epilepsy, that is expected to report topline data by the first half of 2022."

Financing • P1 data • CNS Disorders • Epilepsy

Eliem Therapeutics Launches with $80M in Financing (FinSMEs) - "Eliem Therapeutics, Inc....launched with $80m in financing...aims to develop and commercialize therapies treating neuronal excitability disorders such as chronic pain, depression, epilepsy, and anxiety...ETX-155, an investigational next generation neuroactive steroid NCE that acts as a GABAA positive allosteric modulator (PAM), is being evaluated in Phase 1 studies with plans for 2021 trial initiations in multiple indications, including major depressive disorder (MDD), hormone-related mood disorders, and focal onset seizures (FOS)."

Financing • New trial • Trial status • CNS Disorders • Depression • Epilepsy • Major Depressive Disorder