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Cereno Scientific Receives Approval to Initiate FDA-aligned Phase I Pharmacokinetic Study of CS014 Supporting Phase II Development in PH-ILD
Cereno Scientific (NASDAQ First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the Swedish Medical Products Agency has approved the initiation of a Phase I pharmacokinetic study of CS014. The study is designed based on feedback received in a pre-IND meeting with the U.S. Food and Drug Administration (FDA) and is expected to remove the need for additional safety studies and a P
About this update from Cereno Scientific Ab Class B
[{"type":"text","content":"GOTHENBURG, Sweden, March 17, 2026 /PRNewswire/ -- Cereno Scientific (NASDAQ First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the Swedish Medical Products Agency has approved the initiation of a Phase I pharmacokinetic study of CS014. The study is designed based on feedback received in a pre-IND meeting with the U.S. Food and Drug Administration (FDA) and is expected to remove the need for additional safety studies and a Phase IIa trial. This supports a streamlined and capital-efficient development pathway toward the planned Phase II trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in Q1 2027.","length":759,"tagName":"p"},{"type":"text","content":"The approved study is a Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA.","length":433,"tagName":"p"},{"type":"text","content":"Following a constructive pre-IND meeting, the FDA indicated that comparative bioavailability data would be acceptable to support the initiation of a Phase IIb trial with CS014. The pharmacokinetic comparison allows Cereno Scientific to leverage the extensive clinical experience with VPA to strengthen the CS014's safety package. A successful trial is expected to remove the need for additional nonclinical safety studies and a clinical Phase IIa trial, allowing Cereno Scientific to progress directly toward Phase IIb preparations.","length":536,"tagName":"p"},{"type":"text","content":""This study represents a regulatory aligned and strategically important step in the continued development of CS014," said Sten R. Sörensen, CEO of Cereno Scientific. "By incorporating FDA feedback early, we have designed a focused pharmacokinetic program that supports efficient progression toward our planned Phase IIb study in PH-ILD and enables a more streamlined development pathway toward potential marketing approval. This reflects our capital-efficient...