Cereno Scientific announced that the Clinical Trial Application (CTA) for a first-in-human, Phase I trial of novel histone deacetylase inhibitor (HDACi) drug candidate CS014, has been approved by the European Medicines Agency. The aim of the planned first-in-human Phase I trial is to evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a single-ascending- and multiple-ascending-dose trial for 1 week.

The title of the study is "A first-in-human, open-label trial to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of CS014 in healthy volunteers after single and multiple administration". The investigational drug candidate CS014 belongs to Cereno's HDAC inhibitor program, capitalizing on the principle of epigenetic modulation. The innovative drug candidate represents a novel approach to antithrombotic treatment without the associated increased risk of bleeding.

CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator - regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular changes and elevated blood pressure. HDAC inhibition as thrombosis prevention could fundamentally change the thrombosis prevention landscape and meet a major unmet medical need.

CS014 is being developed in collaboration with the University of Michigan.