Cereno Scientific has submitted a clinical trial protocol for its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA), marking a significant advancement in its development for pulmonary arterial hypertension (PAH). This submission is a crucial step toward initiating a global Phase IIb trial, which aims to evaluate the safety, tolerability, and efficacy of CS1, an oral histone deacetylase inhibitor (HDACi) targeting the underlying mechanisms of PAH.
The Phase IIb trial is set to build on positive results from the Phase IIa trial, where CS1 demonstrated a favorable safety profile and encouraging efficacy signals, including improvements in vascular remodeling and right heart function. Conducted in collaboration with a leading contract research organization, this multicenter, placebo-controlled trial will also facilitate regulatory interactions in other key regions, reflecting a robust global development strategy.
According to Cereno’s CMO, Rahul Agrawal, the protocol aligns with FDA feedback from a recent Type C meeting, and the company anticipates a 30-day review period before trial initiation. As PAH remains a life-threatening condition with limited treatment options, CS1’s potential to modify disease progression could significantly impact patient outcomes and reshape the therapeutic landscape.
Get started today with Solo access →
