Cereno completes CS014 trial ahead of June top-line data
Cereno Scientific announced today the successful completion of the second and final part of its phase I clinical trial evaluating drug candidate CS014 in healthy volunteers. The milestone was marked by the last patient’s last visit, and top-line results are expected in June 2025.
Cereno Scientific’s pipeline includes three drug candidates – CS1, CS014, and CS585 – all in parallel development for rare cardiovascular and pulmonary diseases. The phase I trial of CS014, conducted in collaboration with CRO partner CTC in Uppsala, is primarily designed to evaluate the candidate’s safety and tolerability in humans.
CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Drug candidate CS014 has shown strong vascular remodeling effects in preclinical studies, which indicates a disease-modifying potential.
CEO highlights market potential and patient impact
The phase I study is divided into two parts, where CS014 was administered as a single ascending dose (SAD), followed by multiple ascending doses over seven days (MAD). The first part was completed in February 2025 and confirmed an acceptable safety and tolerability profile, supporting continued clinical development. The second part has now also been completed.
– We are excited to have reached the `last patient last visit’- milestone for the phase I trial. We believe that CS014 can bring much needed improvement for patients as a well-tolerated oral treatment with a favorable safety profile and disease-modifying capacity. Based on the indicative results from part one of the phase I trial combined with promising effects seen in preclinical models, CS014 has a large market potential with relevance as a treatment for rare cardiovascular and pulmonary diseases with high unmet medical needs, says Sten R. Sörensen, CEO of Cereno Scientific.
Countdown to top-line results
The phase I study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CS014 in 48 healthy volunteers. Following the final follow-up in the MAD part, data processing will now begin, followed by database lock and final analysis. Top-line results are expected in June 2025.
Rahul Agrawal, CMO and Head of R&D of Cereno Scientific, looks forward to the continued development.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.– We are pleased with the progress of the CS014 phase I trial, which has been well executed according to planned timelines. The CRO, CTC in Uppsala, has been an excellent partner in this trial. The safety and tolerability data observed from part one of the trial suggest that CS014 may have a favorable safety profile. We now eagerly look forward to the top-line results, and further clinical development exploring CS014’s potential.
