Aspire Biopharma Holdings, Inc., Announces Last Patient Dosed in Phase 1 Clinical Trial of its Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
Rhea-AI Summary
Aspire Biopharma Holdings (NASDAQ:ASBP) has completed patient dosing in its Phase 1 clinical trial for its oral transmucosal fast-acting high-dose aspirin formulation. The study compares the company's sublingual 162.5 mg aspirin powder against traditional oral aspirin in healthy adult volunteers.
The trial evaluates plasma acetylsalicylic acid concentration, Arachidonic acid-induced platelet aggregation, and Serum thromboxane B2 measurements to assess the formulation's rapid impact on cardiac events. Topline results are expected by mid-Q3 2025, after which Aspire plans to pursue a section 505(b)(2) NDA and explore potential partnership opportunities.
Positive
- Clinical trial patient dosing completed on schedule according to protocol
- Company plans to submit 505(b)(2) NDA for market approval
- Management actively pursuing potential partnership opportunities
Negative
- None.
Insights
Aspire Biopharma completes Phase 1 dosing on schedule; key efficacy data for fast-acting aspirin formulation expected Q3 2025.
Aspire Biopharma has achieved a noteworthy operational milestone with the completion of patient dosing in their Phase 1 trial for a novel sublingual high-dose aspirin formulation. The study's design focuses on comparing their 162.5 mg sublingual powder against traditional oral aspirin, with primary endpoints examining plasma concentration kinetics over 24 hours post-administration.
The trial includes critical secondary measurements of platelet aggregation and serum thromboxane B2 levels over 8 hours—biomarkers that will directly demonstrate if their formulation achieves the rapid onset needed for acute cardiac events. This speed-of-action advantage would be the key differentiator for their product.
From a regulatory perspective, Aspire's planned 505(b)(2) NDA pathway is strategically sound for reformulated products, potentially enabling a more streamlined approval process by leveraging established safety data for aspirin. This approach balances efficiency with lower development costs compared to novel compounds.
While meeting enrollment timelines demonstrates operational competence, investors should recognize that as a Phase 1 study, this trial primarily establishes basic pharmacokinetics and safety rather than definitive efficacy. The true inflection point will come with the Q3 data readout, which will determine whether the formulation achieves the rapid absorption profile necessary to support its value proposition in emergency cardiac care.
The management's mention of potential partnership discussions signals confidence in their preliminary data and recognition that commercializing an emergency cardiac medication would benefit from established distribution channels and sales infrastructure that strategic partners could provide.
Enrollment Completed on Schedule; Topline Results Expected Mid Q3 2025
ESTERO, FL AND NEW YORK, NY / ACCESS Newswire / June 24, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced the last patient was dosed in its Phase 1 single-center clinical study of its oral transmucosal fast-acting high-dose aspirin formulation.
Topline results from the study are anticipated by the middle of third quarter of 2025.
"The successful completion of patient dosing in our Phase 1 trial is a noteworthy accomplishment. We are extremely grateful to the investigator and patients who participated in this study. Achieving this milestone on time and as planned per protocol also demonstrates the operational excellence of our team and clinical partners," said Michael Howe, Chief Executive Officer of Aspire. "We look forward to reporting initial safety and efficacy data in the third quarter, which will provide key insights into our formulation of high-dose aspirin and its potential as a fast-acting treatment option for suspected acute myocardial infarction. Following the receipt of the topline results, we plan to continue discussions with the FDA to ensure our path forward is well-aligned with regulatory expectations."
Howe added, "We are eager to integrate the insights from this trial into our comprehensive development plan. We believe these trial results will also play a key role in our strategy to pursue potential partnership opportunities."
Phase 1 Study Design
The Phase 1 clinical trial, which is being conducted in the United States, compares the pharmacokinetic and pharmacodynamic characteristics of normal healthy adult volunteers after the administration of our sublingual dose of 162.5 mg aspirin powder 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). The trial also measures Arachidonic acid (AA)-induced platelet aggregation over 8 hours after dosing and Serum thromboxane B2 (TxB2) over 8 hours after dosing, both of which are valuable for documenting Aspire's sublingual high-dose aspirin's rapid impact on cardiac events.
Following completion of this trial, Aspire plans to submit a section 505(b)(2) NDA seeking approval to market the high-dose aspirin product.
About the Aspire Targeted Oral Delivery Platform
Aspire's technology delivers a soluble, fast-acting granular or powder formulation which has been developed by using our patent-pending methodology, and "trade secret" process. The technology's new mechanism of action allows for rapid sublingual absorption and entry into the bloodstream of drugs and other substances. The benefits of "rapid absorption" are to provide rapid impact in more precise quantities.
About Aspire Biopharma, Inc.
Headquartered in Estero, Fl., Aspire Biopharma has developed a disruptive technology that can deliver supplements and drugs rapidly and precisely. For more information, please visit www.aspirebiolabs.com.
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
TraDigital IR
Kevin McGrath
+1-646-418-7002
kevin@tradigitalir.com
SOURCE: Aspire Biopharma Holdings, Inc.
View the original press release on ACCESS Newswire
FAQ
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