Aspire Biopharma Holdings, Inc., Announces First Patient Dosed in Phase 1 Clinical Trial for its Lead Program, an Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
- First patient successfully dosed in Phase 1 trial, marking significant pipeline progress
- Potential for accelerated FDA approval pathway if trial successful
- Short timeline to completion (mid-June 2025) and topline data (early Q3 2025)
- Early-stage Phase 1 trial with no guarantee of success
- FDA accelerated approval still subject to regulatory review and feedback
Insights
Aspire's first dosing in Phase 1 trial of fast-acting aspirin marks clinical progress with potential accelerated approval pathway if successful.
Aspire Biopharma's announcement represents a significant clinical development milestone with the initiation of their Phase 1 trial for their lead candidate. This novel formulation is designed as an oral transmucosal fast-acting high-dose aspirin, suggesting potential advantages in absorption speed compared to conventional oral aspirin.
The trial design is particularly informative as a crossover study comparing their sublingual aspirin powder/granules (162.5 mg) against standard oral aspirin tablets of equivalent dosage. The primary endpoint focusing on plasma acetylsalicylic acid concentration will directly measure how quickly and efficiently their formulation enters the bloodstream compared to conventional tablets. The additional measurement of TxB2 (thromboxane B2) is crucial as it serves as a biomarker for aspirin's antiplatelet activity.
The compressed timeline is noteworthy - with completion expected by mid-June 2025 and topline data early in Q3. This accelerated schedule suggests a straightforward trial design with relatively quick pharmacokinetic endpoints rather than long-term clinical outcomes. Most importantly, the company indicates potential for accelerated approval based on this single Phase 1 trial, which would be unusual but possible if the formulation shows dramatic improvements in onset of action with equivalent safety.
For context, faster-acting aspirin formulations could have significant clinical utility in acute coronary syndromes where minutes matter in preventing further clot formation and myocardial damage. If successful, this delivery technology could potentially be applied to other compounds requiring rapid onset of action.
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 TxB2 and its anti-coagulant bioavailability in the volunteers. For additional information on this trial please visit .
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.
About Aspire Biopharma, Inc.
Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which addresses emergencies, drug efficacy, dosage management, and response time. For more information, please visit .
Safe Harbor Statement
Certain statements made in this communication are "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as "estimate," "projects," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "would," "should," "future," "propose," "potential," "target," "goal," "objective," "outlook" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Aspire's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Aspire Biopharma Holdings, Inc.
Contact
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SOURCE: Aspire Biopharma Holdings, Inc.
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FAQ
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