Summit, N.J.-based Engage Therapeutics said today that it closed a $23 million Series A round to fund a Phase IIb trial of its lead product, Staccato alprazolam. The round was led by TPG Biotech, Adage Capital Management and Lumira Capital.
The drug-device product combines a hand-held inhaler technology, which is FDA-approved, with alprazolam, an FDA-approved benzodiazepine. If the FDA OKs the combination product, Engage Therapeutics said it would be the first of its kind indicated to rapidly stop seizure activity.
“Staccato alprazolam is a disruptive drug-device combination with the potential to become an EpiPen-like rescue treatment for people who experience uncontrolled epileptic seizures,” founder, president & CEO Gregory Mayes said in prepared remarks.
“We are grateful for the value our new investors see in this novel drug development program and we look forward to their active involvement as we execute upon a clinical development program that builds on the safety and efficacy data of the Staccato delivery technology with alprazolam, a well-known and established benzodiazepine.”
The company has an exclusive license and supply deal with Alexza Pharmaceuticals to develop the rescue therapy. Engage Therapeutics said it plans to pursue a 505(b)(2) pathway for Staccato alprazolam.
“Benzodiazepines have an established history in the treatment and prevention of epileptic seizures. The Staccato inhaler facilitates rapid administration and uptake of alprazolam, stopping epileptic seizures in a manner of time not previously observed,” TPG Biotech’s lead investor rep Heath Lukatch, added.
“With the financial resources from the Series A, Engage is now able to complete the Phase IIb clinical development program and prepare for additional clinical and regulatory activities necessary to pursue worldwide product registrations.”
In connection with the Series A round, Gerry Brunk, managing director at Lumira Capital, Stephen Collins, president & CEO at Biscayne Neurotherapeutics, and Lukatch have joined the company’s board of directors.
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