|Engage Therapeutics Doses First Patient in Phase 2b Trial of Epilepsy Seizure Rescue Therapy Staccato® Alprazolam|
|May 06, 2018|
Topline Data Expected H2-2019
Peachtree BioResearch Solutions to Execute Multi-Center Trial
SUMMIT, N.J., May 03, 2018 (GLOBE NEWSWIRE) -- Engage Therapeutics, Inc., today announced dosing of the first patient in its multi-center, double-blind, randomized Phase 2b StATES (Seizures) trial to investigate the safety and efficacy of Staccato alprazolam 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 Staccato delivery 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, but Staccato alprazolam 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.