ENX-102 / Engrail Therap - LARVOL DELTA

Biomarker-Based Pharmacological Characterization of ENX-102, a Novel α2/3/5 Subtype-Selective GABAA Receptor Positive Allo-Steric Modulator: Translational Insights from Rodent and Human Studies. (PubMed, Cells) - "Across dose levels, ENX-102 was well tolerated and exhibited favorable pharmacokinetics. These results support further clinical development of ENX-102 as a next-generation GABAAR subtype-selective anxiolytic drug."

Biomarker • Journal • Preclinical • Alzheimer's Disease • Anesthesia • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=252 | Completed | Sponsor: Engrail Therapeutics INC | Recruiting ➔ Completed

Monotherapy • Trial completion • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENX-102 Phase 2 Social Anxiety Disorder (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Engrail Therapeutics INC

Monotherapy • New P2 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

ENX-102-004: A Dose-Response Safety Study of ENX-102 in Patients With GAD (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Engrail Therapeutics INC | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENX-102-004: A Dose-Response Safety Study of ENX-102 in Patients With GAD (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Engrail Therapeutics INC | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Dose-Response Safety Study of ENX-102 in Patients With GAD (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Engrail Therapeutics INC

New P2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Engrail Therapeutics INC | N=200 ➔ 280 | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Engrail Therapeutics INC | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Monotherapy • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Engrail Therapeutics INC

Monotherapy • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Central Target Engagement and Pharmacodynamic Biomarker Profile for 2 Mg ENX-102, a Gaba-A alpha2,3,5 Pam in Development for the Treatment of Generalized Anxiety Disorder (ACNP 2023) - "ENX-102 exhibited a favorable PK profile with a long half-life consistent with once daily oral administration. Central target engagement was evidenced by qEEG changes consistent with sustained reduced arousal and decreased saccadic peak velocity. ENX-102 at 2 mg exhibited a favorable pharmacodynamic biomarker profile with no evidence of sedation, reduced alertness or attention, impaired psychomotor function, or impaired memory."

Biomarker • PK/PD data • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Engrail Therapeutics INC | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2023 ➔ Jul 2023

Enrollment open • Monotherapy • Trial initiation date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ENX-102 Demonstrates Central Target Engagement as a Gamma-Aminobutyric Acid Type a Alpha2,3,5 Positive Allosteric Modulator in a Phase 1b Multiple Ascending Dose Clinical Study in Healthy Volunteers (SOBP 2023) - "Conclusions ENX-102 was safe and well-tolerated. Its PD profile demonstrated central target engagement and indicated sustained reduced arousal that lacked untoward effects on alertness, psychomotor function or memory, a pattern distinct from GABA-AR non-selective BZDs in humans."

Clinical • Late-breaking abstract • P1 data • CNS Disorders

ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Engrail Therapeutics INC

Monotherapy • New P2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry