Cereno Scientific aligns with FDA on CS1 development
Cereno Scientific has taken another important step forward with lead candidate CS1. Yesterday, the Swedish biotech held a constructive Type C meeting with the U.S. Food and Drug Administration. The discussions suggest alignment between Cereno Scientific and the FDA on the development path.
CS1 is an epigenetic modulator and class I HDAC inhibitor with anti-proliferative, anti-inflammatory, and anti-fibrotic properties, currently being developed as a potentially disease-modifying treatment for pulmonary arterial hypertension (PAH). PAH is a rare and progressive condition that affects the pulmonary vasculature and leads to right heart failure.
The candidate has already demonstrated a favourable safety profile, tolerability, and early efficacy signals in a completed phase IIa trial, and Cereno Scientific is now preparing for the next phase of development.
Strategic dialogue with the FDA
To ensure regulatory expectations are met, the company held a Type C meeting with the FDA to discuss the design and strategy for the upcoming phase IIb study. The meeting was part of a broader regulatory engagement.
– It is a sound strategy to seek advice from the authorities several times during the clinical development of a drug candidate to ensure that expectations are aligned from both parties, said Sten R. Sörensen, CEO of Cereno Scientific. Our interactions with the FDA for the lead program CS1 have been insightful, starting with meetings prior to the phase IIa trial, the orphan drug designation (ODD), the Extended Access Program (EAP) and now the Type C meeting in preparation for our phase IIb trial. We look forward to continuing to advance an innovative treatment for people with the severe rare disease PAH.
Aligning with the FDA
The dialogue with the FDA offered insights that can help form the continued clinical development of CS1. The feedback is expected to contribute to the company’s internal considerations as it prepares for the next phase of the programme.
– We had a productive discussion with the FDA regarding the further clinical development of our promising HDAC inhibitor CS1, said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific. The team at the FDA have extensive experience in clinical trials and what is needed for marketing authorizations, so it is very important to utilize the meeting time optimally ensuring that our questions are answered. I am very pleased with the discussions and look forward to receiving the official meeting minutes as an immediate next step for the development program.
Looking ahead
Strengthened by the meeting, Cereno is proceeding with its preparations for a larger, placebo-controlled phase IIb trial aimed at further validating CS1’s therapeutic potential in PAH. The company plans to give an update on CS1’s development once official FDA meeting minutes are received, expected within a month.
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