Cereno Scientific AB announced the submission of a clinical trial application (CTA) to the European Medicines Agency (EMA) for a first-in-human, Phase I study of novel histone deacetylase inhibitor (HDACi) drug candidate CS014. The CTA was submitted for a first in human Phase I study to primarily evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a traditional single ascending and multiple ascending dose study for 1 week.

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 Phase I study is planned to be initiated during second quarter of 2024. 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 in humans. 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 has the opportunity to fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. CS014 is being developed in collaboration with the University of Michigan.