EPIMODE is a global, randomized and placebo-controlled Phase IIb trial designed to evaluate efficacy, safety and tolerability, determine the optimal dose for further development, and provide additional insight into CS1’s potential disease-modifying effects in patients with pulmonary arterial hypertension (PAH). CS1 is being developed by Cereno Scientific as an oral, once-daily, potentially disease-modifying treatment for pulmonary arterial hypertension, intended for use as an add-on to standard of care. It is an HDAC inhibitor acting through epigenetic modulation with a novel therapeutic approach targeting underlying disease-driving mechanisms including vascular remodeling, fibrosis and inflammation.
The timeline: Up to 15 clinical sites are expected to be activated by year-end 2026, with more than 50% of the planned global clinical sites are expected to be activated by the end of Q1 2027. Patient recruitment is planned to be completed during 2027 and topline results continue to be anticipated in Q4 2028.
The study is led by Professor Marc Humbert, Principal Investigator and Chair of the Clinical Steering Committee, together with Professor Sandeep Sahay, University of Houston, as Committee Co-Chair.
Read more at this link on Modular Finance
See also our previous article about CS1 at this link