Engage Therapeutics has announced the initiation of the double-blind, randomized Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of inhaled alprazolam in epilepsy patients who have seizures with a predictable pattern. The company said that topline data should be available in the second half of 2019.
The primary endpoint for the inpatient trial, which is expected to enroll 108 subjects, is cessation of seizure activity. Secondary endpoints include seizure episode severity 6 hours post dosing and use of rescue medication up to 2 hours post dosing.
In late 2015, Alexza announced interim results from a Phase 2a study of Staccato alprazolam for repetitive seizures showing that dose-related decreases in mean standardized photosensivity range (SPR) were observed 2 minutes post inhalation for 2 of the 3 doses tested. That study enrolled 5 patients according to clinicaltrials.gov.
Engage Therapeutics President and CEO Greg Mayes commented, “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.”
In September 2017, Engage announced that it had raised $23 million for development of Staccato alprazolam. The company has acquired worldwide development and commercial rights from Alexza.
Read the Engage Therapeutics press release.
