SUMMIT, N.J. (PRNewswire) — Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a Rapid Epileptic Seizure Termination (REST) therapy for people who experience a predictable pattern of epileptic seizures, today announced it will present clinical data from the open-label portion of the randomized Phase 2b StATES Study (Staccato Alprazolam Terminates Epileptic Seizures) at the 2019 American Academy of Neurology Annual Meeting, which will be held May 4–10, 2019, in Philadelphia.
The poster is entitled, “A Two-Part, Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Patients with Epilepsy with a Predictable Seizure Pattern: Results from the Initial Open-Label Feasibility Part.”
“The Open-Label data are encouraging and we are very pleased to have the opportunity to showcase research that could lay the groundwork for 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. “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.”
Presentation details are as follows:
Presenter: Jacqueline French, M.D.
Session Date and Time: May 5, 11:30 a.m. to 6:30 p.m. EDT
Poster Presentation Number: 5-023
The StATES study will enroll patients from more than 45 trial sites in the U.S., Australia, Canada, and Jamaica. Approximately one hundred fifteen subjects will be enrolled in the double-blind, placebo-controlled portion of the trial which commenced on January 2019.
About Engage Therapeutics, Inc.
Engage Therapeutics, Inc. is developing Staccato alprazolam, for the immediate cessation of active and acute epileptic seizures. The investigational product is in the Rapid Epileptic Seizure Termination (REST) category of products. It is a small, easy-to-use hand-held drug-device combination that leverages a fast-acting FDA-approved delivery system 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 randomized study known as the StATES study. Engage Therapeutics is based in Summit, N.J.
For Additional Information Contact:
Greg Mayes, Chief Executive Officer, (215) 696-9659; gmayes@engagetherapeutics.com
Related Article: Epilepsia Publishes Phase 2a Data for Staccato Alprazolam