Aquestive Therapeutics, Inc. (NASDAQ:AQST) gained ~20% pre-market Tuesday after the company announced that its AQST-109 epinephrine sublingual film compared favorably to other forms of epinephrine treatments, including EpiPen® autoinjector of Viatris (VTRS).
Faster delivery of epinephrine is vital to prevent the progression of anaphylaxis to a more severe reaction.
According to topline results from the EPIPHAST II trial, a single dose of AQST-109 led to 12 minutes of Tmax, which indicates the time to reach the maximum plasma concentration.
In comparison, Tmax linked to EpiPen® 0.3mg and epinephrine 0.3mg intramuscular (IM) injection was found to be 22.5 minutes and 45 minutes, respectively. With repeated dosing, AQST-109 was found to have eight minutes of Tmax.
The mean maximum concentration (Cmax) was found to be 465 pg/mL after one dose and 2,958 pg/mL after two doses of AQST-109.
In comparison, EpiPen led to a Cmax of 869 pg/mL after a single dose, and epi 0.3mg IM injection resulted in 489 pg/mL and 911 pg/mL Cmax after one dose and two doses, respectively.
Meanwhile, the maximum mean effects on systolic blood pressure and heart rate occurred after five minutes and eight minutes following AQST-109 compared to eight minutes and an average of five minutes within administering EpiPen, respectively.
“We are pleased to see that AQST-109 compared favorably to both the EpiPen and the epi 0.3mg IM injection across several measures,” Chief Executive Daniel Barber.
The company plans to share the complete data set with the FDA at an end-of-Phase 2 meeting scheduled for Q4 2022.
Read more on the upcoming catalysts outlined by AQST management in August.