Aquestive Therapeutics Inc (NASDAQ:AQST) announced positive topline results from Part 1 of the EPIPHAST study for its AQST-109 epinephrine oral film.
- Part 1 showed that key pharmacokinetic measures were aligned with previous favorable results for AQST-109 and that the product was well tolerated with no serious adverse events.
- A lead candidate is currently being evaluated in Part 2 of the EPIPHAST study.
- The lead formulation of AQST-109 rapidly reached clinically meaningful blood concentrations when delivered in two different physical configurations, with a median Tmax of 13.5 minutes and 22.5 minutes, respectively.
- Also See: See Why Aquestive Therapeutics Shares Are Down More Than 30%.
- Part 1 data also demonstrated that arithmetic mean maximum concentrations values consistent with those previously reported for approved injectable epinephrine devices such as EpiPen.
- EPIPHAST is a crossover study in healthy adult subjects comparing the pharmacokinetics and pharmacodynamics of epinephrine delivered via Aquestive's AQST-109 oral film compared to intramuscular injection of epinephrine.
- Aquestive has commenced Part 2 of the EPIPHAST study and expects to report topline results in the first half of 2022.
- Part 2 is a randomized, crossover design comparing AQST-109 12mg to epinephrine IM 0.3mg.
- Price Action: AQST shares are up 7.66% at $2.67 during the market session on the last check Friday.
