Trial marks key milestone in driving pipeline progress

Phase 1 trial scheduled for completion mid-June 2025

Topline data from High-Dose Aspirin Trail anticipated early in 3Q with the potential to support an accelerated approval, subject to FDA feedback

HUMACAO, PR and NEW YORK, NY / ACCESS Newswire / May 20, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today 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 (approximately two 81 mg aspirin tablets). The primary outcome measure will be plasma acetylsalicylic acid (ASA) concentration versus time data (pre-dose and up to 24 hours post dose.) This trial will also provide important data about T_xB₂ and its anti-coagulant bioavailability in the volunteers. For additional information on this trial please visit www.clinicaltrials.gov.

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.

"Dosing the first patient in our oral transmucosal fast-acting high-dose aspirin formulation study is an important milestone for Aspire as we continue the clinical development of our lead product candidate," said Kraig Higginson, Chief Executive Officer of Aspire. "We are proud that our aspirin formulation is one step closer to our goal of addressing several key unmet needs, and we are grateful to our patients for participating in this trial."

About the Aspire Targeted Oral Delivery Platform

Aspire's technology delivers a soluble, fast acting granular or powder form drug formulation which has been developed by using our patent-pending methodology, and "trade secret" process. The technologies new mechanism of action allows for rapid sublingual absorption and entry into the bloodstream. The benefits of "rapid absorption" are to provide nearly instant treatment impact and high dose absorption. The Company's patent-pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs into the blood stream, thus by-passing the gastrointestinal tract, and potentially provide an improved treatment outcome.