Cereno Scientific's HDACi CS014 Completes Phase I SAD Safety Trial

Cereno Scientific, a pioneering biotechnology company focused on developing treatments for rare cardiovascular and pulmonary diseases, has announced significant progress in the clinical trial of its innovative drug candidate, CS014. This promising histone deacetylase (HDAC) inhibitor is being developed to treat idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease. The first segment of the Phase I clinical trial, which tested single ascending doses of CS014 in healthy volunteers, has been successfully completed without any safety issues.

CS014, a novel chemical entity, functions as an HDAC inhibitor and has shown potential in preclinical studies to modify disease symptoms by reversing pathological remodeling of pulmonary vessels and exhibiting anti-fibrotic effects. These properties are particularly relevant for treating IPF, a condition characterized by scarring of the lung tissue which leads to progressive lung function decline. The drug also shows anti-thrombotic effects across various vascular systems, aligning with the unmet medical needs of IPF patients.

The initial phase of the clinical trial was conducted in collaboration with CTC, a contract research organization based in Uppsala. This phase focused on evaluating the safety, tolerability, and pharmacokinetics of CS014 in 30 healthy individuals. The completion of this stage marks a crucial milestone, indicating a favorable safety profile and supporting further clinical development.

Part two of the trial is currently underway, assessing multiple ascending doses of CS014. This portion of the study is anticipated to be completed by mid-2025. Overall, the trial involves approximately 48 participants and is designed to determine the safety, tolerability, and pharmacokinetic properties of CS014. Following the conclusion of the trial, top-line results will be published after thorough data analysis.

Rahul Agrawal, Chief Medical Officer and Head of Research and Development at Cereno Scientific, expressed satisfaction with the progress of the trial, highlighting the successful completion of the initial phase as a strong validation of CS014's safety profile. Sten R. Sörensen, CEO of Cereno Scientific, emphasized the drug’s potential to fill a significant gap in the treatment of IPF by providing a safe, well-tolerated, and disease-modifying oral solution that addresses the underlying pathophysiology of the disease.

Cereno Scientific is committed to extending life and improving the quality of life for individuals suffering from rare cardiovascular and pulmonary diseases. Their innovative pipeline includes CS014 and CS1, another HDAC inhibitor currently in Phase II development for pulmonary arterial hypertension (PAH). The company is also exploring CS585, a prostacyclin receptor agonist with potential applications in thrombosis prevention and pulmonary hypertension.

Headquartered in GoCo Health Innovation City, Gothenburg, Sweden, Cereno Scientific operates a subsidiary in Kendall Square, Boston, Massachusetts. The company is publicly traded on the Nasdaq First North under the symbol CRNO B and continues to make strides in the field of rare disease treatment through cutting-edge research and development.