Aspire announces Phase 1 trial initiation of high-dose aspirin formulation

Aspire Biopharma (ASBP) announced initiation of its Phase 1 single- center clinical study 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 begin during April. 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. The primary outcome measure will be plasma acetylsalicylic acid concentration versus time data. 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 request a pre-IND meeting with the FDA in the second quarter of 2025 to finalize plans for continued development of high-dose aspirin leading to submission of a section 505(b)(2) NDA seeking approval to market the product for treatment of suspected acute myocardial infarction. An oral transmucosal acetylsalicylic acid 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.