Aquestive reports topline data from temperature/pH study of Anaphylm

Aquestive Therapeutics released topline pharmacokinetic data from the temperature / pH study of its product candidate Anaphylm Sublingual Film. Anaphylm is the Company’s first and only orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics of Anaphylm just after consuming normal water, lemon water, and baking soda water. The primary PK parameters were the maximum amount of epinephrine measured in plasma and exposure, or the area under the curve, at various times after dosing, in 30 healthy adult subjects. Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH. The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water. While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water. The table below provides the ratio of Cmax and AUC 0-60min following administration of Anaphylm under various test states when compared to room temperature water. The Company’s remaining supportive studies, inclusive of the self-administration study and the oral allergy syndrome challenge study, are all underway. The self-administration study’s dosing is expected to conclude in the second quarter of 2024, and the OAS challenge study’s initial dosing is expected to occur in July 2024. The table below indicates the remaining clinical studies anticipated before submission of the New Drug Application for Anaphylm.