Emerging Company in the Spotlight sponsored by JFK Communications.
BioNJ is pleased to shine the spotlight on one of our Innovation Members each month featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem. This month’s Emerging Company in the Spotlight is Diaceutics.
So many of our Members are making a dramatic impact on our State’s innovation ecosystem. We celebrate you! Diaceutics is one such company.
In 2014, Greg Mayes’ son was diagnosed with epilepsy. There are currently three million epileptic patients in the United States and only two-thirds with controlled epilepsy. The other one-third of epileptic patients suffer from uncontrollable seizures, exposing the need for a rescue treatment with the potential to rapidly stop active epileptic seizure activity. There are no medications on the market that can stop seizure activity once it has begun.
In late 2016, knowing that Mayes was a pharmaceutical executive, his son’s team of physicians at the NYU Comprehensive Epilepsy Center brought him the idea of developing and commercializing a therapeutic product that could abort an epileptic seizure. Current products provide relief from seizure activity in 15 minutes or more and after the seizure activity has elapsed. Existing therapies seek to prevent additional seizures once a seizure has passed. Today, Mayes is President and CEO of Engage Therapeutics, a start-up biotech headquartered in Summit, NJ that is focused on developing and hopefully bringing patients with epilepsy the first acute rescue treatment that starts to work in seconds — and within 2 minutes aborts ongoing seizure activity.
In the fall of 2017, backed by top tier blue chip VCs and investors, Mayes licensed the inhaled product, Staccato® alprazolam, from Alexza Pharmaceuticals and formally launched Engage Therapeutics. Staccato® alprazolam combines two proven entities: an inhaler device used in an FDA-approved product, and a widely used benzodiazepine – alprazolam.
Staccato® alprazolam is an easy to use, hand-held inhaler that could be the first epileptic rescue treatment designed to terminate ongoing seizure activity. The inhalation device delivers alprazolam into the deep lung and to the systemic circulation rapidly, with the potential of
ceasing all seizure activity within 2 minutes and providing seizure protection for up to several hours. “We need a treatment that works fast. It’s about time — acting fast and saving lives,” says Mayes.
Clinical Development Program
An earlier Phase 2a trial investigated the potential of Staccato® alprazolam in patients with photosensitive epilepsy. Study results demonstrated a maximal or near-maximal decrease in epileptiform response (primary endpoint) for all doses by the 2-minute time point in 80% of the patients tested, suggesting rapid anti-epileptic activity. The treatment was well tolerated, with no reported serious adverse events (SAEs).
Engage Therapeutics has initiated a Phase 2b clinical trial of Staccato® alprazolam in patients with a predictable epilepsy seizure pattern called StATES (Staccato Alprazolam Terminates Epileptic Seizures). The primary objectives of this clinical trial are to assess:
- Efficacy of Staccato® alprazolam in aborting a seizure episode
- Clinical feasibility and safety of Staccato® alprazolam administration during a seizure episode
- Efficacy and usability in epileptic patients with predictable pattern of seizures
The Next 5-10 Years
If the Phase 2b study demonstrates positive results, the next step will be an end of Phase 2 meeting with the U.S. Food and Drug Administration to discuss the final steps toward registering the product. “If we are successful, epilepsy patients could have an EpiPen® like rescue treatment that works so fast it can abort the active seizure early and prevent additional seizure formation for several hours. A true unmet need.” said Mayes.
Beyond epilepsy, Staccato® alprazolam could also be tested in the future in the treatment of acute panic attack, a U.S. market that is ten times the size of the epilepsy market. Ultimately, Mayes hopes Engage Therapeutics will attract a pharmaceutical partnership that can help him bring Staccato® alprazolam to market and the patients who desperately need an option for stopping an epileptic seizure. www.engagetherapeutics.com