(AQST) – Aquestive Highlights Early Data from AQST-109 Study on Allergy Treatment Candidate

Aquestive Therapeutics Inc (NASDAQ: AQST) announced the first positive results from the Part 1 of the EPIPHAST study for its oral epinephrine film AQST-109.

  • 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 effects.
  • A lead candidate is currently being evaluated in Part 2 of the EPIPHAST study.
  • The primary formulation of AQST-109 rapidly reached clinically significant blood concentrations when administered in two different physical configurations, with a median Tmax of 13.5 minutes and 22.5 minutes, respectively.
  • Also see: Find out why Aquestive Therapeutics shares have fallen more than 30%.
  • The Part 1 data also demonstrated that the arithmetic mean peak concentration values ​​were consistent with those previously reported for approved injectable epinephrine devices such as the 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 versus intramuscular injection of epinephrine.
  • Aquestive has started part 2 of the EPIPHAST study and expects to publish the first results in the first half of 2022.
  • Part 2 is a randomized crossover design comparing AQST-109 12 mg to epinephrine IM 0.3 mg.
  • Price action: Shares of AQST rose 7.66% to $2.67 in Friday’s last check trading session.

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