Biotech company Cereno Scientific reports positive top-line results from a Phase I study with CS014. The PK profiles versus VPA were in line with the company’s assumptions, and all 14 participants completed the study without serious adverse events.
According to Cereno, the results strengthen the plan to proceed directly to Phase IIb in PH-ILD without a Phase IIa study or additional non-clinical safety studies, subject to FDA approval. An IND application is planned for the fourth quarter of 2026, and the Phase IIb start for the third quarter of 2027.
