“The Fast Track designation for CS1 underscores the FDA’s recognition of its potential to address the significant unmet need in PAH,” says Rahul Agrawal, CMO & Head of R&D at Cereno Scientific.

“Fast Track designation will enable closer interaction with the FDA, enabling timely feedback on our development plans as we advance CS1 into its Phase IIb trial and beyond. This designation marks an important step in the development journey for CS1 and supports our goal of making innovative treatment options available to PAH patients as efficiently as possible.”

CS1

Drug candidate CS1 is an oral HDAC inhibitor (HDACi) with a mechanism of action through epigenetic modulation. In a Phase IIa trial in PAH, CS1 met its primary endpoint of safety and tolerability while showing encouraging efficacy signals in a Phase IIa trial in PAH, including improvement of REVEAL risk score, functional class, quality of life, and early signs of reverse vascular remodeling and improvement of right heart function, describes the company. A global Phase IIb trial is being prepared to further evaluate CS1 as a potential disease-modifying treatment for PAH.