Engage Therapeutics is focused on bringing patients with epilepsy suffering from uncontrolled seizures what could be the first rescue treatment with the potential to stop their seizures.
Epilepsy affects at least three million people in the United States. One in three of those people have what is considered refractory epilepsy with uncontrolled seizures, as one or more anti-epileptic drugs has not worked for them. Approximately twenty percent or 200,000 of these patients have a predictive pattern of seizures, and Engage Therapeutics is working to bring these patients Staccato alprazolam, which is designed to stop a seizure in patients who have a predictable seizure pattern.
In 2017, the company entered into an exclusive license and supply agreement with Alexza Pharmaceuticals to advance Staccato alprazolam into phase 2b development as a treatment to stop seizure activity. Founded by a leadership team with deep personal and professional experience in epilepsy, Engage Therapeutics is headquartered in Summit, NJ.
Engage Therapeutics is developing Staccato alprazolam, an easy to use, hand-held inhaler that could be the first rescue treatment with the potential to stop epileptic seizure activity. In a phase 2a proof of concept trial, Staccato alprazolam has been shown to abort seizure-like activity in less than two minutes. The therapy, which is entering a phase 2b study, combines the FDA-approved Staccato delivery technology with alprazolam, a well-known benzodiazepine that has potent and effective anti-epileptic properties, to rapidly terminate seizure activity once it has begun. If approved, this would be the first product approved for such an indication. Engage Therapeutics is using the 505(b)(2) regulatory pathway to develop and seek approval for Staccato alprazolam. In a phase 2a study, Staccato alprazolam demonstrated a reduction in seizure-like activity in a Photosensitivity model. The company initiated a phase 2b study called StATES (Staccato Alprazolam Terminates Epilepsy Seizures) in Q1 2018.
Clinical trials are designed to provide information on the benefits, side effects and possible uses for new drugs and existing medications. Results from clinical trials are submitted for review to regulatory agencies, like the U.S. Food and Drug Administration (FDA), which establish safety and efficacy standards for medical products. If a medicine meets these standards, it can be approved and becomes available by prescription.
Engage Therapeutics is working to develop a new rescue therapy for people who experience uncontrolled epileptic seizures.