- Aspire Biopharma has signed an agreement with Microsize to support the development of a 162 mg sublingual aspirin powder for suspected acute myocardial infarction.
- The collaboration is intended to support an upcoming clinical trial and a planned Section 505(b)(2) New Drug Application submission near the end of 2026.
Aspire Biopharma Holdings, Inc. has entered into an agreement with Microsize, a North American contract development and manufacturing organisation (CDMO), to support development of its lead drug candidate, a 162 mg sublingual aspirin powder. The investigational product is being developed for the emergency treatment of suspected acute myocardial infarction.
Microsize, based in Quakertown, Pennsylvania, focuses on cGMP micronisation, particle size reduction and solubility enhancement. Under the agreement, the CDMO will apply its particle engineering capabilities to optimise Aspire’s drug product as part of its contract manufacturing and development activities.
The collaboration is expected to support an upcoming clinical trial and the planned submission of a Section 505(b)(2) New Drug Application near the end of 2026. The clinical study will evaluate serum thromboxane B2 inhibition in 32 healthy volunteers, comparing the 162 mg sublingual aspirin dose with the current standard of care of two chewed 81 mg aspirin tablets.
“This agreement is a critical step in our path forward, and reinforces our commitment to excellence, product quality, and U.S.-based innovation.”
Kraig Higginson, interim chief executive officer of Aspire
According to the company, the agreement aligns with its broader strategy to develop existing, approved therapeutics designed to deliver faster onset of action with fewer side effects.
