Cereno Scientific to evaluate CS1 with advanced imaging technology
Cereno Scientific announces that a sub-study with CS1 within the ongoing Extended Access Program (EAP) now can commence following regulatory approvals. The study will utilise medtech company Fluidda’s imaging technology to deepen the understanding of the drug candidate’s potential to prevent and reverse pathological remodeling of blood vessels in the lung of patients with the rare disease pulmonary arterial hypertension (PAH). Moreover, company has requested a Type C meeting with the FDA to discuss the next development steps for CS1.
Cereno Scientific develops treatments for rare cardiovascular and pulmonary diseases. The company’s portfolio includes three drug candidates – CS1, CS014, and CS585 – which are being evaluated in separate and parallel development programs. CS1 has demonstrated the ability to reversepathological remodeling of blood vessels in preclinical studies. The drug candidate met the primary endpoint in a phase IIa study in PAH patients, completed in the fall of 2024. The study showed that CS1 is safe and well tolerated, with compelling data supporting a disease-modifying treatment effect in combination with standard therapy.
Imaging technology for non-invasive evaluation
One of the major challenges has been demonstrating this effect clinically in a non-invasive manner. Cereno aims to investigate this effect in a sub-study within the ongoing Extended Access Program (EAP), for which the company communicated regulatory approval to start on February 19. The study will utilise Functional Respiratory Imaging (FRI) technology from the U.S. based medical technology company Fluidda. Through advanced CT imaging, researchers will gain detailed insights into structural changes in the small pulmonary arteries and how these are affected by long-term treatment with CS1.
“By using the Fluidda technology, we will be able to obtain detailed images of the patient’s lungs and in so doing, detect changes in the pulmonary vasculature in patients treated with CS1. We believe that by monitoring the treatment response of CS1 with this technology, we will be able to capture signs of CS1’s reverse remodeling effect in PAH patients,” said Rahul Agrawal, CMO & Head of R&D of Cereno Scientific.
Study design and expected outcomes
The sub-study, referred to as “the Fluidda study”, will involve selected patients within the EAP program undergoing three CT scans over a 12-month period. Through this long-term follow-up, researchers aim to visualise how CS1, in combination with standard therapy, affects the characteristic structural changes in small pulmonary arteries. The results could provide critical insights into whether CS1 treatment can increase blood vessel volume and thereby improve lung function in PAH patients. It is also expected to provide additional data to support future clinical development steps.
“Our hope is to offer a pioneering approach to PAH therapy uniquely using HDAC inhibition as a mode of action in cardiovascular and pulmonary disease. CS1, part of our HDACi portfolio, targets the pathophysiology of disease progression in PAH with the potential to prevent or reverse vascular remodeling,” said Sten R. Sörensen, CEO of Cereno Scientific.
Next steps in development
The EAP program, which includes 10 patients, is an extension of the previous phase IIa study and aims to collect long-term data on the treatment’s safety and efficacy. The program is FDA approved and is expected to provide key insights for upcoming regulatory interactions and the planning of future phase IIb or pivotal phase III studies.
On February 20, Cereno also announced that it had submitted a request for a Type C meeting with the FDA regarding the continued development of CS1. The goal of the meeting is to establish a shared understanding with the FDA regarding the ongoing development plan for the drug candidate. In accordance with FDA’s timeline, the meeting is expected to take place within 75 days.
“This is another major milestone for our lead program CS1 in the rare disease PAH. We are continuing to make good progress on our promising CS1’s development program,” commented Sten R. Sörensen.
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