Engage Therapeutics Phase 2b StATES trial meets primary endpoint
Category: #health  By Saipriya Iyer  Date: 2020-03-13
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Engage Therapeutics Phase 2b StATES trial meets primary endpoint

Engage Therapeutics, Inc., a clinical stage pharmaceutical company, has recently announced that the primary endpoint of its Phase 2b StATES clinical trial of Staccato® alprazolam has been met. The multi-center study was designed to evaluate the usability, efficacy, and safety of Staccato® alprazolam among adult patients, in an in-patient environment, who are suffering from generalized or focal epilepsy with a predictable seizure pattern.

The study results are slated to release at the AAN (American Academy of Neurology) Annual Meeting to be held in Toronto in April 2020.

The study has contributed towards the achievement of seizure termination, with epilepsy patients undergoing treatment administration of Staccato® alprazolam achieving seizure activity cessation in 2 minutes or less, with no recurrence incident within 2 hours. Engage Therapeutics has been continuously focusing on developing the orally inhaled epilepsy therapy for immediate termination of any active seizure.

The double-blind portion of the study had enrolled 116 patients, who were randomized to any one of two treatment arms or placebo. Out of total 76 patients in the two treatment arms, 50 patients have achieved the primary endpoint of seizure termination with no recurrence. Within 2 minutes, the seizure rescue treatment showed rapid onset of action in an average of 30 seconds, with mild adverse events, which include throat irritation, sedation, dizziness, dysgeusia and cough. Somnolence was the most common adverse event, which occurred among 11 out of 76 patients.

The Phase 2b StATES study’s principal investigator, Jaqueline French has reportedly stated that the favorable result of the study will enable the trial team to bring an EpiPen®-like seizure rescue therapy soon, for the treatment of any active seizure episode. The Phase 3 study is also expected to be initiated by conducting the trial in an outpatient enviroment by 2020 end.

As per Engage Therapeutics’ CEO and Founder, Gregory T. Mayes, the data or results achieved from the Phase 2b study, with Staccato® alprazolam posing as a tool for epilepsy patients to quickly stop seizures, can help further advance clinical services.

Source credit:

https://www.globenewswire.com/news-release/2020/03/12/1999155/0/en/Engage-Therapeutics-Announces-Phase-2b-StATES-Study-of-Staccato-Alprazolam-for-Seizure-Cessation-Meets-Primary-Endpoint.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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