- Aspire Biopharma (ASBP, Financial) initiates a Phase 1 clinical trial for a novel sublingual high-dose aspirin.
- Trial compares pharmacokinetics and pharmacodynamics of the sublingual formulation against standard oral aspirin.
- Potential benefits include rapid absorption, increased bioavailability, and reduced gastric irritation.
Aspire Biopharma Holdings, Inc. (ASBP) has announced the commencement of a Phase 1 clinical trial for its innovative oral transmucosal fast-acting high-dose aspirin formulation. Conducted at a single center, this trial will assess the safety, pharmacokinetics, and pharmacodynamics of a 162.5 mg sublingual aspirin powder compared to conventional oral aspirin.
The study will enroll 6-8 participants beginning in April 2025, focusing on the plasma acetylsalicylic acid concentration over a 24-hour period. This early-stage trial aims to establish the foundational pharmacokinetic and pharmacodynamic data necessary for future development and optimization of the aspirin product.
Aspire plans to seek a pre-Investigational New Drug (IND) meeting with the FDA in the second quarter of 2025. The goal is to discuss development strategies for a 505(b)(2) New Drug Application (NDA) submission, targeting treatment for suspected acute myocardial infarction. The aspirin formulation is anticipated to offer rapid absorption and enhanced bioavailability, potentially reducing the risk of gastric irritation.
Kraig Higginson, CEO of Aspire, highlighted the significance of this trial as a crucial step toward providing direct delivery of high-dose aspirin via the bloodstream. This method bypasses the gastrointestinal tract, aiming for improved efficacy through rapid absorption, possibly minimizing adverse gastrointestinal reactions.
Preliminary data from the trial is expected by the end of the second quarter of 2025, providing valuable insights into the pharmacokinetic properties of the sublingual aspirin formulation.
