Cereno Scientific launches initiative for data quality control of CardioMEMS HF System providing an opportunity to report early efficacy data in Q4
Cereno Scientific (Nasdaq First North: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced an initiative to control the data quality produced from the cutting-edge technology CardioMEMS HF System (Abbott Inc.) used to daily monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics during the Phase II study of CS1. The remarkable patient case study presented in June triggered the initiative for data quality control of CardioMEMS measurements to ensure optimal data quality for CS1 in this study. Ultimately, the data quality control will support a conclusive study result from this new CardioMEMS HF System technology in a new disease indication. The aim is to provide a report from the data quality control in Q4 2023. This enables Cereno to communicate efficacy data on more than half of the study population receiving CS1 in Q4 2023.
A data quality control at this stage of the study enables the opportunity to correct deviations from the set protocol or issues around data transfer from the home to the clinic with the aim to increase standardization of the data. This quality control aims to provide an opportunity to optimize protocol adherence and data transfer quality and contribute to that efficacy data will be conclusive. This also means an opportunity to report efficacy data as early as Q4 2023.
"Data from all patients in the study will be reviewed as one group since the blinding for dose will remain. Our aim is primarily to report that the data gathering is working well, and the data quality is high. Higher data quality means that we will have a better ability to observe the effects of CS1 in patients with PAH at an early stage of development. Even if the data will be blinded in the quality analysis, we aim to further confirm indication of efficacy potential since all patients are treated with different doses of CS1, although in a blinded fashion," said Gunnar Olsson, lead of the data quality control initiative, member of the Clinical Steering Committee of the Study and the Cereno Scientific Advisory Board, and renowned cardiologist.
"CS1 has thus far indicated to be an efficacious treatment alternative as recently observed in the investigator-initiated patient case study. We noted that CS1 showed a 30% reduction in PAH and a 20% increase of cardiac output. Notably, the patient's status was improved from NYHA/WHO functional class II to functional class I at the end of the treatment period. This is just data from one patient upon which no definitive conclusions can be made but I am very excited to follow this study to its end and commend this initiative for optimal data quality," said Raymond Benza, System Director of Pulmonary Hypertension at Mount Sinai Icahn School of Medicine, New York City, US; Chair of the Study Clinical Steering Committee and Cereno Scientific Advisory Board.
"We are pleased to see CardioMEMS being evaluated in a new indication, especially in a debilitating rare disease such as PAH. The daily remote monitoring that CardioMEMS provides is a game-changer for patients with PAH as the physician can follow the patient's pulmonary hemodynamics and treatment effects. We are eager to see the results of the data quality control initiative," said Phil B. Adamson, MD, MSc Divisional Vice President and Chief Medical Officer of the Heart Failure Division, Abbott.
"Cereno is a pioneer in drug development, and we have received accolades for the innovative study design with the use of the CardioMEMS HF System technology in this Phase II study. We are eager to ensure that the data quality of all patients enrolled in the study is rigorously controlled to ensure a high level of standardization. Triggered by the patient case study, the purpose of this initiative is to create an optimal, conclusive data set for the outcome of the study with a strong, clear indication of the effect of CS1 as measured by CardioMEMS HF System," said Sten R. Sörensen, CEO of Cereno.
The Phase II study of CS1 in the rare disease PAH is currently actively recruiting patients at 9 specialist clinics in the US, and two new clinics are planned to open. 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 patients with the rare disease PAH. The top-line results are estimated to be reported in Q1 2024.
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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.