Aspire Biopharma Holdings, Inc., Announces Institutional Review Board Approval for In-Human Clinical Trial of an Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
Rhea-AI Summary
Aspire Biopharma (Nasdaq: ASBP) has received Institutional Review Board (IRB) approval for its Phase I clinical trial of a novel oral transmucosal fast-acting high-dose aspirin formulation. The trial, set to begin this week, will involve 6-8 participants at a single U.S. center.
The study will compare a 162.5 mg sublingual aspirin powder against standard oral aspirin in healthy adult volunteers, measuring plasma acetylsalicylic acid concentration over 24 hours. This innovative delivery method aims to bypass first-pass metabolism through oral mucosa absorption.
The company plans to pursue FDA fast-track approval via a 505(b)(2) NDA for treating suspected acute myocardial infarction. Previous research has shown aspirin treatment reduced vascular mortality risk by 23% in MI patients. The new formulation could potentially offer improved bioavailability while limiting gastric irritation associated with traditional aspirin delivery.
Positive
- IRB approval received for Phase I clinical trial of fast-acting high-dose aspirin formulation
- Clinical trial site activated with immediate trial commencement expected this week
- Potential fast-track FDA approval pathway identified through 505(b)(2) NDA
- Product targets acute myocardial infarction market where aspirin shows 23% reduction in vascular mortality risk
- Technology potentially offers improved bioavailability by avoiding first-pass metabolism
Negative
- Small initial trial size of only 6-8 participants indicates early-stage development
- Additional clinical trials may be required before FDA approval
- No revenue generation at current stage
- Competitive market for aspirin-based products
Insights
IRB approval enables Aspire's Phase I trial of fast-acting aspirin delivery, advancing clinical validation of potential emergency cardiac treatment.
Aspire Biopharma has secured Institutional Review Board approval for their Phase I clinical trial, a necessary regulatory milestone that enables the company to begin testing their oral transmucosal fast-acting high-dose aspirin formulation in human subjects. This development transitions their lead candidate from preclinical to clinical stage, with patient enrollment of 6-8 participants expected to commence this week.
The trial will evaluate three critical parameters: safety, pharmacokinetics, and pharmacodynamics of their sublingual powder formulation versus conventional oral aspirin. This comparison will determine whether their delivery technology achieves the hypothesized faster absorption profile, which could be particularly valuable in acute myocardial infarction scenarios where rapid platelet inhibition is crucial.
Aspire's 505(b)(2) regulatory strategy leverages existing safety data on aspirin while focusing on demonstrating their formulation's potential advantages. The company has identified two potential benefits: faster absorption through oral mucosa (bypassing first-pass metabolism) for emergency use and reduced gastric irritation for chronic users.
While this IRB approval represents standard procedural progress, it confirms Aspire is executing on its clinical development timeline. The small trial size is appropriate for initial pharmacokinetic assessment but will only provide preliminary evidence of their technology's potential advantages.
Aspire's IRB-approved Phase I trial will assess sublingual aspirin's pharmacokinetics for potential faster absorption in acute cardiac events.
Aspire's IRB approval enables clinical evaluation of their sublingual aspirin powder delivery system, which targets a clinically significant need: faster platelet inhibition during suspected heart attacks. The trial will compare a 162.5mg sublingual formulation against equivalent oral aspirin, with plasma concentration measurements over 24 hours as the primary endpoint.
The scientific rationale is sound: by bypassing first-pass metabolism through oral mucosal absorption, acetylsalicylic acid could potentially reach therapeutic levels faster than conventional oral administration. This timing difference could be clinically meaningful in acute myocardial infarction, where the article cites research demonstrating aspirin's 23% reduction in vascular mortality risk.
The trial design appropriately focuses on pharmacokinetics in healthy volunteers, which will establish whether the formulation achieves its primary technical objective. If successful, this data would inform subsequent studies potentially targeting two distinct applications: emergency use during suspected heart attacks and daily use for patients requiring chronic antiplatelet therapy.
The sublingual delivery mechanism may offer a secondary benefit of reduced gastric irritation by avoiding direct stomach contact, potentially addressing a common side effect of long-term aspirin therapy. However, this Phase I study focuses primarily on absorption parameters rather than clinical outcomes, representing an early but necessary step in validating the company's drug delivery technology.
Company achieves another milestone relating to its clinical trial strategy
HUMACAO, PR and NEW YORK, NY / ACCESS Newswire / April 29, 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 it has received Institutional Review Board (IRB) approval of the clinical trial protocol for its upcoming 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.
One clinical trial site has been activated with patient enrollment expected to total six to eight participants and the trials are expected to begin this week.
"The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research," said Kraig Higginson, Chief Executive Officer of Aspire. "With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the clinical trial of our oral transmucosal fast-acting high-dose aspirin formulation and look forward to its commencement."
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.) More information can be found at https://clinicaltrials.gov/
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 submit a section 505(b)(2) NDA seeking fast-track 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.
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.
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
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