Aspire Biopharma Holdings, Inc., Announces Phase 1 Clinical Trial Initiation of its Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
One clinical trial site activated
Patient enrollment expected in April
Trial designed to evaluate safety, pharmacokinetics and pharmacodynamics, of Aspire's sublingual aspirin product
Aspire anticipates releasing initial clinical data from trial at the end of the second quarter
Aspire intends to request "fast track" approval on FDA application for its high-dose aspirin product
HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / April 9, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today announced initiation of its Phase 1 single- center clinical study of its lead therapeutic candidate, an oral transmucosal fast-acting high-dose aspirin formulation.
One clinical trial site has been activated with patient enrollment expected to total six to eight participants and begin during April.
Phase 1 Study Design
The objectives of this Phase 1 single dose clinical study are to evaluate the safety, pharmacokinetics and pharmacodynamics of Aspire's sublingual aspirin powder when administered orally in healthy adult volunteers. The Phase 1 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 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 Phase 1 trial is expected to provide information required to select the optimal drug product formulation and inform the design of a second clinical trial, if needed, to support FDA approval. Following completion of this trial, Aspire plans to request a pre-IND meeting with the FDA in the second quarter of 2025 to finalize plans for continued development of high-dose aspirin leading to submission of a section 505(b)(2) NDA seeking approval to market the product for treatment of suspected acute myocardial infarction. An oral transmucosal acetylsalicylic acid (OTASA) product associated with rapid absorption and antiplatelet effects could provide important benefits for patients experiencing acute myocardial infarction where the benefits of aspirin in reducing the risk of vascular mortality are widely recognized and where every minute counts. In a large, multicenter study of aspirin, streptokinase, and the combination of aspirin and streptokinase in 17,187 patients with suspected acute MI, aspirin treatment produced a 23 percent reduction in the risk of vascular mortality. Aspirin was also shown to have an additional benefit in patients given a thrombolytic agent. (Source: https://pubmed.ncbi.nlm.nih.gov/2903874/ )
Greater bioavailability of ASA, through the oral mucosa (avoiding first pass metabolism) could also potentially improve pharmacodynamic effects of aspirin for patients on repeated-dose aspirin regimens while limiting the potential for direct irritation to the gastric mucosa that could be associated with gastric bleeding.
"Initiation of this trial represents a critical step toward establishing additional clinical evidence for our novel therapeutic approach of targeted, rapid sublingual delivery of high dose aspirin directly to the bloodstream, which we believe could lead to better outcomes for patients," said Kraig Higginson, Chief Executive Officer of Aspire. "Direct delivery to the bloodstream and bypassing the gastrointestinal tract with our high dose aspirin product has potential for improved efficacy driven by more rapid absorption, while reducing or eliminating adverse reactions in the gastrointestinal tract for patients."
Higginson continued, "By evaluating the time to peak concentration of our aspirin formulation in this phase 1 trial, we expect to receive important insight into the pharmacokinetic and pharmacodynamic effects of our high dose sublingual aspirin, in addition to safety data. We anticipate faster absorption and increased drug levels when compared with conventional oral aspirin. We look forward to sharing preliminary data from the study towards the end of the second quarter."
About High Dose Sublingual Aspirin
Aspire's lead product candidate, high dose sublingual aspirin, is a granular or powder formulation of a soluble, Ph neutral, fast-acting aspirin designed to address cardiology emergencies and pain management. Aspire believes the benefits of "rapid absorption" aspirin include the potential to quickly address cardiac incidents much earlier in the "golden hour" where intervention can save lives, allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief.
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 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.
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SOURCE: Aspire Biopharma Holdings, Inc.
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