The extensive study preparations are now translating into site-level clinical execution, with the first EPIMODE site operationally cleared to begin screening and recruitment. This marks a concrete step toward first patient randomization and dosing and establishes the foundation for recruitment capacity to expand as additional specialist PAH centers are activated, the company states.

“Activating the first clinical site is an important operational step that enables patient screening to begin in the EPIMODE trial. Despite important advances in the treatment of PAH, there remains a need for therapies that go beyond managing symptoms and hemodynamics and address the underlying disease biology. With EPIMODE, we aim to rigorously evaluate whether CS1’s epigenetic approach can contribute to that next step. Building on the encouraging observations from our Phase IIa trial and Expanded Access Program, the study is designed not only to assess efficacy and dose response, but also to deepen our understanding of CS1’s potential disease-modifying effects. The strong engagement from participating PAH investigators during our investigator meeting reinforces our belief that this is an important scientific question for the field,” said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific.