Engage Therapeutics said that the Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of Staccato inhaled alprazolam in epilepsy patients has met its primary endpoint, terminating seizure activity within two minutes of dosing with no recurrence in 50 of 76 patients. Engage had announced the initiation of the study in April 2018.
According to the company, the average time to cessation of seizure activity was approximately 30 seconds after the patient received Staccato alprazolam. No treatment-related serious adverse events were reported.
Staccato platform developer Alexza, which was acquired by Grupo Ferrer in 2016, initiated a Phase 2a trial of Staccato alprazolam in January 2015 and announced interim results from that study at the end of that year. The Staccato aerosol device is also used to deliver Adasuve Staccato loxapine, which was approved by the FDA in December 2012 and was approved in Europe in February 2013.
Engage Therapeutics Founder and CEO Gregory T. Mayes commented, “As a parent, I have personally experienced the need for a product that can work fast enough to terminate an active seizure when it occurs. We believe these data from the StATES study show what we hoped could be done – can be done. As we move the clinical development forward, we want to see Staccato alprazolam become a tool that patients with epilepsy can use to rapidly stop a seizure.”
Principle Investigator Jaqueline French of the NYU Langone Health Comprehensive Epilepsy Center said, “With statistically significant and clinically meaningful Phase 2 results in this randomized, placebo-controlled trial, Staccato alprazolam has demonstrated the ability to rapidly terminate seizures in patients with epilepsy in two minutes or less and prevent recurrence of seizure within two hours. We are now one step closer to bringing to patients an EpiPen-like rescue treatment that works fast enough to terminate an active seizure episode. We look forward to initiating a Phase 3 study in the outpatient setting later this year.”
Read the Engage Therapeutics press release.
