ENGAGE THERAPEUTICS DOSES FIRST PATIENT IN PHASE 2B TRIAL OF EPILEPSY SEIZURE RESCUE THERAPY
Topline Data Expected H2-2019
Peachtree BioResearch Solutions to Execute Multi-Center Trial
SUMMIT, N.J. – May 3, 2018 – Engage Therapeutics, Inc., today announced dosing of the first patient in its multi-center, double-blind, randomized Phase 2b StATES (Staccato®Alprazolam Terminates EpilepticSeizures) trial to investigate the safety and efficacy of Staccatoalprazolam in subjects with epilepsy that have a predictable seizure pattern.
The StATES trial (NCT03478982) will enroll 108 patients across 40 U.S.-based clinical sites. The primary endpoint is the cessation of seizure activity. Seizure episode severity as well as the incidence of adverse events will also be evaluated. Topline data is expected in the second half of 2019. Staccato alprazolam, a single use, investigational epileptic seizure rescue therapy, combines the Staccatodelivery technology, which is currently used in a U.S. Food and Drug Administration (FDA)–approved product, with alprazolam, an FDA-approved benzodiazepine. Together, this combination is novel for an epilepsy application in a patient population in need of innovative rescue options.
Greg Mayes, president, CEO and founder of Engage Therapeutics, said, “For individuals with epilepsy that have a predictable seizure pattern, currently available rescue treatments can only address the prevention of seizure activity once the first seizure ends, butStaccatoalprazolam has the potential to be the first and only product that can abort an active seizure. We are excited by the enthusiastic response that this study has received from the epilepsy community and how quickly we have been able to advance this promising candidate to this point in development.”
Kristy Nichols, president and co-founder of Peachtree Bioresearch Solutions, a growing clinical research organization in the U.S., added, “Engage is the type of client we seek – an emerging CNS focused company with a novel therapy that addresses a significant unmet medical need. We are confident that our deep clinical trial management experience for CNS disorders and our demonstrated passion for partnership will result in a mutually successful outcome.”
About Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam, for the cessation of active and acute epileptic seizures. The investigational product is a small, easy-to-use hand-held drug-device combination that leverages a fast-acting delivery system already used in an FDA-approved product with FDA-approved alprazolam. Staccato alprazolam demonstrated reduction of seizure-like activity in a photosensitivity model in a Phase 2a proof of concept study. The product has now proceeded into a Phase 2b study known as the StATES trial. Engage Therapeutics is a private company based in Summit, N.J. For additional information please see www.EngageTherapeutics.com.
Entering its 10thyear, Peachtree BioResearch Solutions, Inc. is a Clinical Research Organization that specializes in providing clinical development services for emerging to mid-sized biotechnology, pharmaceutical, and medical device companies. With a highly-experienced clinical development team, Peachtree offers Clinical Project Management, Clinical Monitoring, Medical Monitoring, Biometrics (data management and statistical analysis), Technical Report Writing, Quality Assurance, and Clinical Staff Resourcing. Starting with one client at inception, Peachtree has grown its portfolio to over 65 clients providing services ranging from niche projects to full support. For additional information, visit www.peachtreebrs.com.
Greg Mayes Engage Therapeutics firstname.lastname@example.org
Vice President, Marketing & Business Development email@example.com