Focused on performing a series of preliminary preclinical studies:
- Efficacy studies: time-window studies; dose-response assays and determination of the optimal dose; comparative studies with rtPA.
- Preliminary pharmacokinetics studies. Candidate half-life has been determined.
- Preliminary toxicology studies. Candidate MTD (maximum tolerable dose) has been established. These studies took place between 2015 and 2017.
Regulatory preclinical studies (GLP) necessary to get authorizations for developing clinical trials in humans. This stage focused 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 ended with the Investigational New Drug (IND) Application. Preclinical studies started in the first quarter of 2017 and completed during the second 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 authorization in April 2019, first patient has been recruited in June 2019. Study completion is expected by November 2019.
Phase IIa trial (PoC) will assess neuroprotective effect of ApTOLL in a limited number of acute stroke patients. It is expected to be developed between 2020 and 2021.