Aspire Biopharma Begins Phase 1 Trial of High-Dose Aspirin Formulation

Aspire Biopharma Holdings, Inc. (Nasdaq: ASBP) has announced the dosing of the first patient in a Phase 1 clinical trial for its oral transmucosal, fast-acting, high-dose aspirin formulation. This study, conducted in the U.S., aims to evaluate the safety and pharmacokinetics of the aspirin when administered orally to healthy adults. The trial will compare the effects of a sublingual 162.5 mg aspirin dose to that of traditional oral aspirin, with a focus on plasma acetylsalicylic acid concentration over a 24-hour period.

Completion of this trial is expected by mid-June 2025, with topline data anticipated early in the third quarter. If results are positive, the trial could expedite approval, subject to the FDA's review. CEO Kraig Higginson highlighted this development as a key milestone in addressing unmet medical needs.