Aspire Biopharma announces results from trial of sublingual aspirin product

Aspire Biopharma (ASBP) announced final results from its randomized, crossover bioavailability trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of Aspire’s investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets in healthy adults. The final results demonstrated that Aspire’s sublingual aspirin product produced higher and more rapid mean plasma concentrations of acetylsalicylic acid compared to chewed aspirin tablets, as detailed in Aspire’s previous press release. The product was also safe and well-tolerated by patients, and no adverse events were reported. However, even more clinically significant results were discovered since the press release announcing top-line results was issued on August 18, 2025. Aspire’s OTASA BA2039 sublingual formulation also significantly inhibited serum thromboxane B2 within the first two minutes after dosing compared to the chewed oral aspirin tablets. TxB2 is a biomarker for the effect of aspirin on platelet aggregation. This has significant and important positive implications for its role in the inhibition of blood clotting and its role in heart attacks. These important results underscore the potential of Aspire’s sublingual aspirin product to be the market-leading treatment for suspected acute myocardial infarction. There are an estimated 18 million Americans living with coronary artery disease with approximately 800,000 per year experiencing an AMI leading to 300,000 deaths. Aspirin should be initiated with a loading dose in patients with ACS without an absolute contraindication as soon as possible on presentation irrespective of final management strategy.” Aspire’s sublingual product rapidly delivers 162.5 mg of aspirin, precisely in the range suggested by this study, and Aspire’s product begins to show TxB2 inhibition in two minutes or less.” The results of Aspire’s clinical study suggest that sublingual administration of aspirin provides earlier drug exposure and platelet inhibition than the current standard-of-care, which is chewing and swallowing uncoated aspirin tablets. Numerous published studies indicate that an even more rapid pharmacodynamic effect would be desirable during the early phase of thrombus evolution in the setting of myocardial infarction or ischemic stroke. Reducing mean serum TxB2 concentration after aspirin dosing-which the clinical study demonstrates that Aspire’s sublingual aspirin product does rapidly, starting in 2 minutes or less–indicates successful inhibition of platelet aggregation, which may reduce the risk of vascular death and other major adverse cardiovascular events. Aspire plans to review its clinical trial results with the U.S. Food and Drug Administration to enable a potential regulatory submission for accelerated approval in the third quarter of 2025.