Engage Therapeutics Successfully Completes Open Label Portion of Phase 2b StATES Study and Begins Enrollment in Double-Blind Placebo-Controlled Portion

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Trial evaluating safety and efficacy of Staccato Alprazolam in subjects with epilepsy and a predictable seizure pattern

Results from the open label portion of the study will be presented at a major medical meeting in 2019

NEW ORLEANS, Dec. 03, 2018 (GLOBE NEWSWIRE) — Engage Therapeutics today announced from the American Epilepsy Society’s Annual Meeting the successful completion of the open label portion of the StATES (Staccato Alprazolam Terminates Epileptic Seizures) study. Enrollment will now commence in the double blind, placebo-controlled portion of the study. Results from the open label portion of the study will be presented at a major medical meeting in the first half of 2019.

“We are very pleased to be moving one step closer in our research toward validating what could ultimately become an ultra-rapid option for acute seizure rescue treatment,” said Dr. Jaqueline French, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health, in the Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. French currently serves as the Epilepsy Foundation Chief Scientific Officer.  “Many patients with epilepsy live with the fear that a seizure may occur at any moment, highlighting the need for a rescue medication that could give patients the confidence that a seizure could be rapidly aborted.”

The StATES study is investigating the safety and efficacy of Staccato Alprazolam in subjects with epilepsy who have a predictable seizure pattern. The therapy combines the FDA-approved Staccato delivery technology with alprazolam, an FDA-approved benzodiazepine.

“We are grateful for the contributions of those who participated in the open label portion of the Phase 2b study and want to encourage people to visit www.epilepsyhealthstudy.com to determine whether they, or someone they know, may be a good candidate to join the double-blind placebo-controlled portion of the trial, and help us to more quickly make this therapy’s promise a reality,” said Greg Mayes, president, CEO and founder of Engage.

Engage Therapeutics has lined up 50 U.S.-based clinical trial sites for the StATES study, in addition to sites in Australia, Canada and Jamaica as part of an effort to increase accessibility for participants. One hundred subjects are needed for the double blind, placebo-controlled portion of the trial which should be completed in the second half of 2019. A map of U.S. site locations can be found online at www.engagetherapeutics.com/study-locations.

About Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam, for the immediate 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 study. Engage Therapeutics is based in Summit, N.J. For additional information please see www.EngageTherapeutics.com.