Pipeline

Introduction

We have a broad clinical and preclinical pipeline focused on neuronal excitability conditions of the central and peripheral nervous system. Each program targets a clinically validated mechanism of action for the diseases it is addressing. Our lead drug candidate is ETX-155 for major depressive disorder (MDD) and focal onset seizures (FOS).

Product Candidates (Mechanism) Programs Preclinical Phase 1 Phase 2 Phase 3
ETX-155
(GABAA receptor PAM)
Major depressive disorder (MDD)
Focal onset seizure (FOS)
Kv7 Program(Kv7.2/3 potassium channel opener)
Next Generation Anxiolytic(2,3-benzo)
Pain, Epilepsy, Depression
Generalized anxiety disorder (GAD)
Product
Candidates
(Mechanism)
Kv7 Program
(Kv 7 .2/3 potassium
channel opener)
Next Generation
Anxiolytic

(2,3-benzo)
Programs
Major
depressive
disorder
(MDD)
Focal
onset
seizure
(FOS)
Pain
Epilepsy
Depression
Generalized
anxiety
disorder
(GAD)
Preclinical
Phase 1
Phase 2
Phase 3

ETX-155

Our lead clinical program is ETX-155 for use in multiple disorders of high unmet need, including major depressive disorder (MDD) and focal onset seizures (FOS). ETX-155 is an investigational oral, next generation, neuroactive steroid NCE that acts as a GABAA positive allosteric modulator (PAM) designed to address the shortcomings of other molecules targeting the GABAA channel. We believe it has the potential to be a best-in-class treatment.

Unmet Clinical Need

There is significant unmet need for new treatments for mood disorders and epilepsy.

MDD affects approximately 35 million adults globally, causing significant impairment to daily life1. While there are effective therapies available for individuals suffering from MDD, there is considerable variability in patient responsiveness. There is a pressing need for safe, well tolerated, and rapidly acting antidepressants that reliably provide clinical improvement faster than the up to 6 weeks associated with standard of care SSRIs/SNRIs.

Epilepsy affects approximately 4.7 million people globally, with approximately 1 million of these patients experiencing uncontrolled focal onset seizures (FOS) that are refractory to multiple anti-seizure medications (ASMs)2,3,4. FOS patients have a high prevalence of psychiatric co-morbidities like depression, and for many patients, their current ASMs have a negative impact on mood. There is a pressing need for new ASMs that not only reduce the number of seizures but also provide a positive effect on mood.

The Science of ETX-155

ETX-155 is an investigational novel, oral, next generation, neurosteroid GABAA PAM that demonstrates dual synaptic and extrasynaptic receptor activity with an approximate 24-hour half-life and no clinically meaningful food effect. Preclinical and Phase 1 clinical data demonstrate the potential for ETX-155 to be a best-in-class treatment for multiple neuronal excitability disorders.

ETX-155 is an investigational oral neuroactive steroid GABAA receptor positive allosteric modulator (PAM) that binds at the neurosteroid site on extrasynaptic and synaptic receptors. Binding at the extrasynaptic and synaptic receptors causes enhanced GABAergic tone and GABAergic synaptic transmission, respectively, leading to decreased neuron excitability and firing.

Clinical Trials for ETX-155

ETX-155 has completed Phase 1 clinical trials in healthy subjects and is now being developed in multiple proof-of-concept trials in patients with major depressive disorder and epilepsy.

Preclinical Pipeline

Eliem is progressing a pipeline of preclinical candidates for other neuronal excitability disorders, with two programs currently in advanced discovery stage.  Our lead preclinical program is a Kv7.2/3 channel opener. The Kv7.2/3 mechanism has been validated through regulatory approvals of multiple first generation Kv7.2/3 channel openers, which showed powerful efficacy but subsequently had to be withdrawn from the market due to significant safety issues. Eliem is focused on harnessing the efficacy of the Kv7.2/3 channel approach while significantly enhancing its safety and tolerability profile.  Eliem is also developing a next generation non-sedating anxiolytic based upon a clinically validated mechanism.

 

 

References

  1. DRG, Unipolar Depression Disease Landscape & Forecast. Sept 2020
  2. DRG, Epilepsy Disease Landscape & Forecast. Jan 2021
  3. Epilepsy Foundation
  4. Picot MC et al. The prevalence of epilepsy and pharmacoresistant epilepsy in adults: A population-based study in a Western European country. Epilepsia 2008;49(7):1230-1238

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