Aphios claims that it manufactures pharmaceutical-grade APH-0703 following cGMP guidelines utilising patented manufacturing technology.
The grant will be utilised to develop and evaluate conventional and nanotechnology formulations of APH-0703; measure pharmacologic efficacy in the brain and plasma compartments; cGMP manufacturing of the active pharmaceutical ingredient and nanoformulated drug product at the pilot-scale level.
It will also help the company to establish a Drug Master File; design IND-enabling preclinical studies and Phase I/II clinical trials; and draft IND package for the US FDA.