Aquestive advances oral epinephrine plan after clearing phase 1

Daniel Barber, chief operating officer at Aquestive (Aquestive)

Aquestive Therapeutics has unveiled a second-generation epinephrine prodrug designed to address the limitations of its lead oral sublingual film. The candidates are designed to provide an alternative to the injectable formulations currently used to treat anaphylaxis.

As Aquestive sees it, epinephrine auto-injectors such as EpiPen suffer from multiple problems. Not all patients at risk of serious allergic reactions carry in-date autoinjectors with them, and many people are unsure how to properly use the devices. Unintentional injections are another problem and cause of adverse events.

New Jersey-based Aquestive is using sublingual film and prodrug technology to provide patients with another option. The goal is to overcome vasoconstriction to provide strong, consistent absorption and the rapid relief patients need during anaphylaxis. 

Aquestive recently completed a phase 1 trial in 28 healthy volunteers to assess whether its lead anaphylaxis candidate AQST-108 meets that goal. The study, coupled with an earlier trial, showed recipients quickly absorbed AQST-108, but the conversion of the prodrug into epinephrine was slower than desired. 

Having generated the data, Aquestive plans to meet with the FDA in the second half of the year to discuss the next steps for AQST-108. Aquestive is also looking beyond AQST-108 to a next-generation product designed to minimize conversion time. 

“We have taken the learnings from the AQST-108 studies regarding absorption and conversion and have applied them to the development of our second generation prodrug, AQST-109. We plan to commence a phase 1 PK trial with AQST-109 and anticipate a topline data readout in the second half of 2021,” Dan Barber, chief operating officer of Aquestive, said in a statement.