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Aspire Biopharma Holdings, Inc., Announces Last Patient Dosed in Phase 1 Clinical Trial of its Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
Enrollment Completed on Schedule; Topline Results Expected Mid Q3 2025 ESTERO, FL AND NEW YORK, NY / ACCESS Newswire / June 24, 2025 / Aspire Biopharma
About this update from Aspire Biopharma Holdings, Inc.
[{"type":"text","content":"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 DesignThe 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 ...