ES-481 / Avalo Therap, ES Therap - LARVOL DELTA

A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ES-481 After Oral Administration in Healthy Volunteers. (PubMed, Eur J Drug Metab Pharmacokinet) - "ES-481 doses up to 100 mg were found to be safe and well tolerated. There were no safety findings in this study of concern, and all of the adverse events related to the administration of ES-481 were mild and transient This study describes the pharmacokinetic parameters of ES-481 for the proposed efficacious dose range of 75-100 mg/day of ES-481 for the treatment of DRE."

Journal • P1 data • PK/PD data • CNS Disorders • Epilepsy

Efficacy and Safety of ES-481, a Novel TARP Inhibitor, in Drug-resistant Epilepsy: A Double-blind Randomized Placebo Controlled Phase IIa Trial (AAN 2024) - P2a | "ES-481 demonstrated evidence of anti-seizure efficacy compared to the placebo in patients with DRE. ES-481 dosing up to 75 mg bid was safe and well tolerated."

Clinical • P2a data • CNS Disorders • Epilepsy • Hematological Disorders

Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy (clinicaltrials.gov) - P2a | N=24 | Recruiting | Sponsor: ES Therapeutics Australia Pty Ltd | Trial completion date: Oct 2022 ➔ Dec 2023 | Trial primary completion date: Mar 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • CNS Disorders • Epilepsy

Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients With Essential Tremors (clinicaltrials.gov) - P2a | N=24 | Recruiting | Sponsor: ES Therapeutics Australia Pty Ltd | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Essential Tremor • Movement Disorders