Focused on performing a series of preliminary preclinical studies:
- Complete efficacy studies: dose-response assays and determination of the optimal dose; comparative studies with rtPA.
- Preliminary pharmacokinetics studies. Candidate half-life will be determined.
- Preliminary toxicology studies. Candidate MTD (maximum tolerable dose) will be established. These studies will take place between 2015 and 2017.
Complete regulatory preclinical studies (GLP) necessary to get authorizations for developing clinical trials in humans. This stage focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in early-stage clinical studies. And ends with the Investigational New Drug (IND) Application. Preclinical studies will start in the first quarter of 2017 and is expected to be finished during the first quarter of 2018.
Clinical trials phase I and phase II
Phase I trial objective is to determine the safety profile of the therapeutic candidate. The study pretends to demonstrate that ApTOLL is safe at different doses in a number of healthy volunteers. After obtaining the approvals, trials are expected to start in the 2nd quarter of 2018 and continue through the end of 2018.
Phase IIa trial will assess the effectiveness of the candidate with a limited number of patients. It is expected to be developed between 2019 and until the first half of 2020.