Aspire announces first patient dosed in Phase 1 trial of aspirin formulation

Aspire Biopharma (ASBP) announced that the first patient has been dosed in its Phase I single-center clinical trial in the United States designed to evaluate safety, pharmacokinetics and pharmacodynamics, of its lead therapeutic candidate, an oral transmucosal fast-acting high-dose aspirin formulation. The objectives of this Phase 1 single dose clinical study are to evaluate the safety, pharmacokinetics and pharmacodynamics of Aspire’s sublingual aspirin powder and granules when administered orally in healthy adult volunteers. The Phase 1 “crossover” clinical trial, which is being conducted in the United States, will compare the pharmacokinetic and pharmacodynamic characteristics of normal healthy adult volunteers administered a sublingual dose of 162.5 mg aspirin powder or granules with control healthy subjects given 162.5 mg oral aspirin. The primary outcome measure will be plasma acetylsalicylic acid concentration versus time data. This trial will also provide important data about TxB2 and its anti-coagulant bioavailability in the volunteers. The Company expects to disclose topline data from its high-dose aspirin trial early in the third quarter and if successful, this trial has the potential to support accelerated approval, subject to FDA review.