ETX-810 / Climb Bio - LARVOL DELTA

"$ELYM Phase 2a trial investigating ETX-810 for the treatment of lumbosacral radicular pain (LSRP) did not meet its primary endpoint" (@BioStocks)

P2a data • Pain

Eliem Therapeutics Provides ETX-810 Program Update (GlobeNewswire) - P2a | N=148 | NCT04778592 | Sponsor: Eliem Therapeutics (UK) Ltd. | "Phase 2a clinical trial of ETX-810 in lumbosacral radicular pain (LSRP) did not achieve the primary endpoint; ETX-810 program will be discontinued...Eliem Therapeutics, Inc...reported results from its Phase 2a clinical trial investigating ETX-810 for the treatment of lumbosacral radicular pain (LSRP). In the Phase 2a clinical trial in LSRP, ETX-810 did not achieve statistically significant separation from placebo on the trial’s primary endpoint, which assessed the change from baseline to week 4 in the weekly average of the daily pain score measured with the Pain Intensity Numerical Rating Scale (PI-NRS). This result is consistent with the lack of separation from placebo observed in the Phase 2a clinical trial in DPNP, as reported in April 2022. Therefore, the Company has elected to discontinue further development of ETX-810."

Discontinued • P2a data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain • Peripheral Neuropathic Pain

Eliem Therapeutics to Host Virtual Investor Event on July 21, 2022 (GlobeNewswire) - "Eliem Therapeutics, Inc...announced it will host a virtual investor event on Thursday, July 21, 2022 starting at 10:30 a.m. ET....The event will provide an in-depth review of the lumbosacral radicular pain (LSRP) treatment landscape, the unmet clinical need in this indication, and ETX-810’s clinical program and potential commercial opportunity."

Clinical • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Efficacy and Safety of ETX 018810 in Subjects With Lumbosacral Radicular Pain (clinicaltrials.gov) - P2 | N=148 | Completed | Sponsor: Eliem Therapeutics (UK) Ltd. | Recruiting ➔ Completed

Trial completion • Pain

Eliem Therapeutics Announces Last Patient Completed Dosing in Phase 2a Study of ETX-810 in Patients with Lumbosacral Radicular Pain (LSRP) (GlobeNewswire) - "Eliem Therapeutics, Inc...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....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."

P2a data • Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Eliem Provides Update on ETX-810 and ETX-155 Clinical Programs (GlobeNewswire) - P2 | N=167 | NCT04688671 | Sponsor: Eliem Therapeutics (UK) Ltd. | "Eliem Therapeutics...today reported results from its Phase 2a clinical trial investigating ETX-810 for the treatment of diabetic peripheral neuropathic pain (DPNP)....In the Phase 2a clinical trial in DPNP, ETX-810 did not achieve statistically significant separation from placebo on the trial’s primary endpoint, which assessed the change from baseline to week 4 in the weekly average of the daily pain score measured with the Pain Intensity Numerical Rating Scale (PI-NRS)....The company has also fully enrolled its Phase 2a proof-of-concept trial evaluating ETX-810 in patients with LSRP....The LSRP study has enrolled 149 patients and has a similar design to the Phase 2a DPNP study. The LSRP study is expected to report topline data in the third quarter of 2022."

Enrollment closed • P2 data • Back Pain • CNS Disorders • Diabetic Neuropathy • Lumbar Back Pain • Pain • Peripheral Neuropathic Pain

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

Clinical

Eliem Therapeutics : Investor Presentation dated March 28, 2022 - Form 8-K (Market Screener) - "Primary Outcome Measure: Lumbosacral Radicular Pain (LSRP). Change from baseline to Week 4 in weekly average of the daily pain score 4 Weeks Study + 1 Week Follow up • Rated on 11-point pain intensity Anticipated topline data numerical rating scale (PI-NRS) R ETX-810 (1000mg BID) 2H 2022. 80% power to detect a 1-point difference from placebo N = 122 Placebo BID NCT04778592 Implementing clinical development strategies to refine patient population and limit placebo effect."

P2 data • Back Pain • Lumbar Back Pain • Pain

Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=167 | Completed | Sponsor: Eliem Therapeutics (UK) Ltd. | Recruiting ➔ Completed

Trial completion • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Eliem Therapeutics Host Virtual Investor Event Featuring Opinion Leaders in Chronic Pain Research on February 16, 2022 (GlobeNewswire) - "Eliem Therapeutics, Inc...today announced it will host a virtual investor event, featuring two opinion leaders in chronic pain, that will be held on Wednesday, February 16, 2022 starting at 10:30 a.m. ET....The event will provide an in-depth review on the unmet needs in chronic pain treatment, the precedent data supporting the mechanism of ETX-810, and ETX-810's clinical program and its potential commercial opportunity."

Clinical • Preclinical • Back Pain • CNS Disorders • Lumbar Back Pain • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of ETX 018810 in Subjects With Lumbosacral Radicular Pain (clinicaltrials.gov) - P2; N=122; Recruiting; Sponsor: Eliem Therapeutics (UK) Ltd.; Trial completion date: Oct 2021 ➔ Jul 2022; Trial primary completion date: Oct 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Pain • MRI

Eliem Therapeutics Reports Third Quarter Financial and Business Highlights (GlobeNewswire) - "Eliem Therapeutics, Inc...today reported financial results and business highlights for the quarter ended September 30, 2021....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....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."

P2a data • Back Pain • Central Neuropathic Pain • CNS Disorders • Diabetic Neuropathy • Lumbar Back Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=162; Recruiting; Sponsor: Eliem Therapeutics (UK) Ltd.; Trial completion date: Oct 2021 ➔ Mar 2022

Clinical • Trial completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

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 sets terms for $81 million IPO (Renaissance Capital) - "Eliem Therapeutics, a Phase 2a biotech developing therapies for neuronal excitability disorders, announced terms for its IPO on Monday....Eliem is 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. Its two lead candidates are ETX-810, a novel palmitoylethanolamide prodrug initially being developed for diabetic peripheral neuropathic pain (DPNP) and pain associated with lumbosacral radiculopathy (LSR, or sciatica)..."

Financing • Back Pain • CNS Disorders • Diabetic Neuropathy • Epilepsy • Lumbar Back Pain • Pain • Peripheral Neuropathic Pain

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 is currently evaluating ETX-810, an investigational novel prodrug of the bioactive lipid palmitoylethanolamide, in two Phase 2a clinical trials in patients with diabetic peripheral neuropathic pain and lumbosacral radicular pain, with topline data expected in the first half of 2022."

Financing • P2a data • Back Pain • Diabetic Neuropathy • Lumbar Back Pain • Pain • Peripheral Neuropathic Pain

Eliem Therapeutics Emerges from Stealth with $80 Million Invested to Progress Multiple Clinical Stage Assets Targeting Neuronal Excitability Disorders (PRNewswire) - "The company is progressing two clinical stage assets with clinically validated mechanisms of action for neurological diseases. ETX-810, an investigational new chemical entity (NCE) for chronic pain, which acts via the palmitoylethanolamide (PEA) pathway, is being evaluated in two Phase 2a trials in lumbosacral radicular pain (chronic sciatica) and diabetic peripheral neuropathic pain."

Financing • New P2a trial • Back Pain • Diabetic Neuropathy • Lumbar Back Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of ETX 018810 in Subjects With Lumbosacral Radicular Pain (clinicaltrials.gov) - P2; N=122; Recruiting; Sponsor: Eliem Therapeutics (UK) Ltd.

Clinical • New P2 trial • Pain