Overview
Aspire Biopharma Holdings, Inc, developer of a multi-faceted patent-pending drug delivery technology, announced the last patient was dosed in its phase 1 single-center clinical study of its oral transmucosal fast-acting high-dose aspirin formulation.
The timely enrollment- Enrollment is completed on schedule and top-line results from the study are anticipated by the middle of third quarter of 2025.
Statement from Michael Howe: CEO of Aspire
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, CEO 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 US 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 trial: Comparing the pharmacokinetic and pharmacodynamic characteristics
- 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.
Plans for NDA approval- 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 Aspire & it’s cutting edge technology
- 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.
