Aquestive Therapeutics’ oral epinephrine film has cleared another hurdle on its path to a pivotal clinical trial, holding its own against the intramuscular injection incumbent in a study of healthy volunteers.
The candidate, AQST-109, is designed to deliver epinephrine, the active ingredient used in products such as EpiPen to treat anaphylaxis. While injectable therapies for anaphylaxis are available, Aquestive thinks it can improve on the current offerings using its oral film technology. The technology could make it easier for people at risk of anaphylaxis to carry in-date countermeasures and eliminate the risk of unintentional injections.
“With so many patients not benefiting from a rescue medicine due to a variety of reasons, from needle phobia to delayed administration, an epinephrine oral film like AQST-109 would provide patients with a rescue medication where they need it, when they need it, and in a form they prefer,” Aquestive CEO Keith Kendall said in a statement.
Aquestive originally pitched AQST-108 as the solution to those problems, only for a clinical trial to find it converted from a prodrug into epinephrine at a suboptimal rate. The finding led Aquestive to advance AQST-109, a next-generation candidate designed to minimize conversion time.
In the second, 24-subject part of its AQST-109 study, Aquestive found the median time to maximum concentration in recipients of the 12-mg dose of its oral film was 15 minutes, compared to 50 minutes for the epinephrine 0.3-mg intramuscular injection. The median time to reach the expected threshold for hemodynamic effects was eight minutes for AQST-109, versus 10 minutes for the injection.
Aquestive expects to start the third part of the trial this month. If everything goes to plan, Aquestive will start a pivotal pharmacokinetic trial in the second half of the year as it seeks data to support a filing for FDA approval via the 505(b)(2) pathway.