This trial aims to harness Fluidda’s imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. It seeks to provide valuable insights into CS1’s potential to transform PAH treatment, states the companies. 

Cerano also recently presented topline results from their Phase IIa trial evaluating the safety, tolerability and exploratory efficacy of CS1 in patients with PAH. CS1 was demonstrated to be safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters including improvement of REVEAL risk score, functional class and mean Pulmonary Arterial Pressure (mPAP), states the company. CS1 Phase IIa study data, together with preclinical information, is consistent with reversing pathological remodeling.

“Key results from the study demonstrate both that the primary endpoint was met with good safety and tolerability of CS1 in patients with PAH, and, in addition, we also show a positive impact already after 12 weeks on clinical parameters meaningful to patients and regulatory authorities. These results, together with our foundation of preclinical data, strengthen our conviction that CS1 is a disease-modifying therapy for PAH. We are excited to now move forward with the next development phase with CS1. Our mission is to deliver a drug addressing the pathological remodeling which is progressing the PAH disease and to provide a valuable addition to the PAH toolbox of therapeutics,” says Sten R. Sörensen, CEO, Cereno Scientific.

CS1

CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for PAH. CS1 targets the root cause of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries, which is a hallmark feature of PAH.

FRI

CT-based Functional Respiratory Imaging (FRI) has been developed by Fluidda and enables the visualization and quantification of regional lung structures. FRI is not only able to assess the effect of respiratory therapies, it is also used to define respiratory disease stage, assess disease progression, and can act as a companion diagnostic in surgical procedures. Fluidda FRI technology can quantify regional structures of the lungs in great detail, making it a valuable tool in Cereno Scientific’s further development of CS1 in PAH. This allows the Company to study CS1’s effect and disease-modifying capacity through reverse remodeling in PAH patients.