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Cereno Scientific Reports Favorable Safety and Tolerability after 12 Months of CS1 Treatment in PAH from the Expanded Access Program
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 initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value p
About this update from Cereno Scientific Ab Class B
[{"type":"text","content":"GOTHENBURG, Sweden, March 31, 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 initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value proposition of CS1 as an oral, once-daily potentially disease-modifying therapy.","length":630,"tagName":"p"},{"type":"text","content":"The Expanded Access Program (EAP) enrolled ten patients who had completed the Phase IIa trial, enabling continued treatment with CS1 under physician supervision. Initial learnings from the completed 12-month treatment period show that CS1 was well tolerated, with no unexpected safety concerns observed. No deaths were reported, and no discontinuations were reported to be related to CS1. Six out of ten patients completed the full 12 months of continuous treatment with CS1. Of the remaining patients, two discontinued CS1 treatment following atrial fibrillation events, which was assessed as not related to CS1; one withdrew consent, and one was lost to follow-up.","length":666,"tagName":"p"},{"type":"text","content":""These results provide important confirmation that the favorable safety and tolerability profile observed in the Phase IIa trial is maintained over longer-term use. In PAH, where existing therapies can be associated with safety and tolerability challenges, there remains a significant unmet need for safer, well-tolerated treatment options. These findings support the continued development of CS1 as a potential disease-modifying therapy," said Rahul Agrawal, CMO and Head of R&D of Cereno Scientific.","length":515,"tagName":"p"},{"type":"text","content":"The EAP was conducted under a formal FDA protocol and initiated following requests from patients and physicians. It enabled the generation of additional long-term data beyond the three-month Phase IIa trial, which had demonstrated that CS1 had favorable safety and tolerability and showed encouraging efficacy signals, including improvements in right heart function, functional class and pat...