Cereno Scientific's CS1 Receives FDA Approval for Global Phase IIb Trial in PAH Indication
Cereno Scientific's CS1 Receives FDA Green Light for Phase IIb Trial
Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotechnology company specializing in treatments for rare cardiovascular and pulmonary diseases, has reached a significant milestone. The U.S. Food and Drug Administration (FDA) has granted clearance for Cereno to launch their Phase IIb trials for CS1, aimed specifically at tackling pulmonary arterial hypertension (PAH). This landmark decision is a pivotal step toward addressing a critical medical need.
Background on PAH and CS1
Pulmonary arterial hypertension (PAH) is a severe condition characterized by increased blood pressure in the pulmonary arteries, ultimately leading to heart failure if left unaddressed. Current treatment options are largely focused on symptom management, leaving many patients without effective solutions to modify the disease's progression.
CS1 is an innovative oral treatment being developed by Cereno, acting through epigenetic modulation. This unique mechanism targets the fundamental causes of PAH, such as inflammation and vascular remodeling, rather than just alleviating symptoms. Previous studies have shown promise, with CS1 demonstrating a favorable safety profile and the potential to significantly improve patient outcomes.
Details of the Phase IIb Trial
The Phase IIb study, formally named