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Cereno Scientific Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)
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 U.S. Food and Drug Administration (FDA) has granted clearance to initiate the company's Phase IIb trial of its lead drug candidate CS1 for the treatment of pulmonary arterial hypertension (PAH). The FDA's decision enables Cereno to advance toward first patient in (FPI) in Q2 2026, with top-line
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[{"type":"text","content":"GOTHENBURG, Sweden, Dec. 8, 2025 /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 U.S. Food and Drug Administration (FDA) has granted clearance to initiate the company's Phase IIb trial of its lead drug candidate CS1 for the treatment of pulmonary arterial hypertension (PAH). The FDA's decision enables Cereno to advance toward first patient in (FPI) in Q2 2026, with top-line data anticipated around Q4 2028, subject to enrollment timelines. The clearance follows constructive regulatory interactions and builds on the favorable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1 has also been granted Orphan Drug Designation and Fast Track designation in the U.S.","length":894,"tagName":"p"},{"type":"text","content":""Our goal with CS1 is to address the underlying mechanisms that drive PAH, not simply manage symptoms," said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific. "The planned Phase IIb trial is designed to determine the optimal dose for a Phase III trial and to assess CS1's potential to meaningfully reduce pulmonary vascular resistance and improve functional capacity when added to today's standard therapies. Building on the encouraging signals observed in our Phase IIa study, we believe CS1 could offer a differentiated and disease modifying approach for patients living with this rare and fatal disease."","length":646,"tagName":"p"},{"type":"text","content":"The Phase IIb trial is formally titled "A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study, to Compare the Efficacy and Safety/Tolerability of CS1 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)." It is a global, multicenter trial enrolling approximately 126 patients with PAH who are stable on background therapy. During the first 36 weeks of treatment, participants will be randomized to receive once-daily CS1 capsules at one of two dose levels or matching placebo. At Week 36, all participants will be re-randomized: those initially receiving CS1 will be assigned either to continue on their CS1 dose or switch to pl...