Cereno Scientific to open two new clinics to complete patient recruitment in the Phase II study of CS1 in PAH as top-line results are estimated in Q1 2024
Cereno Scientific (Nasdaq First North: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced that further mitigation strategies have been activated for the Phase II study of CS1 in pulmonary arterial hypertension (PAH) due to slower patient recruitment than anticipated. Two new specialist clinics with large capacities are currently in the start-up phase to open to complete the recruitment of patients fulfilling the study criteria. Consequently, the timeline of the study estimates top-line results to be reported in Q1 2024.
The Phase II study of CS1 in the rare disease PAH is currently actively running at 9 specialist clinics in the US. The two new clinics to open have already identified suitable patients for screening before being activated. At existing clinics, there are potential patients due to be screened during September and October. To date, there are 25 patients enrolled in the study, 16 patients having received CardioMEMS HF System implantation, 16 patients randomized and in active treatment, and 3 patients having completed the study. The study is designed to include 30 randomized patients with the rare disease PAH.
"We are very pleased that our sites have continued to enroll patients in the study since last reported in May. During the summer months, however, we have had a lower patient recruitment pace than anticipated. Our Cereno team has worked closely with the study Principal Investigator, our partner Abbott and the CRO to support the participating clinics. We believe that opening two new clinics with known large capacities will support patient recruitment to complete the study and mitigate any further changes to the study timelines," said Björn Dahlöf, CMO of Cereno.
"Supported by our partner Abbott and key thought leaders in the PAH space, we are committed to developing a better treatment alternative for patients with the debilitating rare disease PAH. We strongly believe that our HDAC inhibitor CS1 has that game-changing potential for PAH patients. As observed in the one-patient case study reported in June, CS1 showed remarkably positive indications to be an effective drug in PAH patients that, hopefully, can not only improve quality of life but also prolong the lives of patients," said Sten R. Sörensen, CEO of Cereno.
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This information is information that Cereno Scientific AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 (CEST) on August 23, 2023.
About Cereno Scientific AB
Cereno Scientific is a clinical-stage biotech company within cardiovascular diseases. The lead drug candidate, CS1, is a Phase II candidate in development for the treatment of the rare disease pulmonary arterial hypertension (PAH). CS1 is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties, all relevant for PAH. A clinical Phase II study is ongoing to evaluate CS1's safety, tolerability, and efficacy in patients with PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Cereno also has two promising preclinical drug candidates in development for cardiovascular disease through research collaborations with the University of Michigan. Drug candidate CS014 is a novel HDAC inhibitor with epigenetic effects, selected for prevention of thrombosis as target indication. In preclinical studies it has been documented to regulate platelet activity, ﬁbrinolysis and clot stability for prevention of thrombosis without increased risk of bleeding. Thrombosis prevention in venous or arterial and cardiovascular disease has been selected as the first indication area for CS014. Drug candidate CS585 is a prostacyclin receptor agonist that has been documented in preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding. The company is headquartered in Gothenburg, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). More information on www.cerenoscientific.com.