Cereno Scientific announced that the preclinical safety program for drug candidate CS014 has successfully been completed. The safety documentation is a key component needed to apply for permission from regulatory authorities to start a first-in-human Phase I study. The Phase I study will be conducted in Sweden in partnership with the contract research organization (CRO) Clinical Trial Consultants (CTC) and is planned to start during the first half of 2024.

Drug candidate CS014 is a histone deacetylase inhibitor (HDACi) in development as a treatment for arterial and venous thrombosis prevention. This innovative drug candidate represents an approach to antithrombotic treatment so far shown to be without the associated increased risk of bleeding. The preparations before a Phase I study can be initiated includes completion of the preclinical development program, including a preclinical safety program, development and manufacturing of the investigational formulation used for oral dosing of the healthy volunteers and obtaining permission from the Swedish Medical Products Agency as well as the Ethics Committee to start the study.

The Phase I study is estimated to be initiated in the first half of 2024.