Cereno Scientific reports 1/3 of patients recruited into CS1 Phase II study in rare disease Pulmonary Arterial Hypertension (PAH)
Cereno Scientific (XSAT: CRNO B) today announced significant progress in the recruitment of patients into the study in the rare disease PAH with its lead candidate drug CS1. Now, a total of 10 patients have been enrolled into the study which plans to study 30 patients.
We are now pleased to announce significant progress in the number of patients having had successful screening visits that are the first visit for a patient in the study.
After all centers being activated in February and the new amendment being in place a high activity of active pre-screening started in all centers and a fair amount of eligible patients were identified for starting in the study.
At the end of March, 10 patients have been consented and had their first successful visit in the study, 3 of them have already been randomized, as previously reported, and now 7 additional patients have entered the study and are now on track for randomization. We expect several more patients to enter the study in the coming weeks to be on track for topline results at the end of year.
“It is great to finally see recruitment taking off after an unforeseen extended start-up and activation phase. With all centers active in the screening process, and with amended eligibility criteria to facilitate identification of patients for screening visits and enrollment, we are now starting to see the real effect of these activities. Already, 1/3 of the patients have consented and entered the study with a successful first visit. We foresee that our target to enroll 30 patients who meet the criteria are being recruited into the study in the coming months,” says Björn Dahlöf, Chief Medical Officer (CMO) at Cereno.
As previously reported, Cereno has received the US FDA’s orphan drug designation (ODD) for the clinical development program for CS1 in PAH, which indicates that they believe CS1 has the potential to provide significant benefit to patients suffering from PAH.
“The unmet medical need for patients with PAH is a treatment challenge. We believe our drug candidate CS1 has the potential to meet that challenge, to make a major difference in the future treatment landscape and I am happy that we now can announce real progress in patient recruitment in this innovative study, says Sten R. Sörensen, CEO at Cereno.”
About the Phase II study with CS1 in PAH
Patient recruitment starts with the patients undergoing a pre-screening and identification process out of the clinics patient registries and study physicians knowledge about their patients. Patients that fulfil all inclusion criteria and none of the exclusion criteria are scheduled for a first visit in the study, where patients consent to participation in the study and all criteria are checked again. If all is in order, the patient has started the study (been recruited into the study with a successful screening visit). About 2 weeks after the first visit the patient is subject to right heart catheterization and implantation of the CardioMEMS HF System to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After another 4 to 6 weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are measured, and the patient is randomized to one of three doses of CS1.The active treatment period is 12 weeks. To enable exploration of CS1’s safety, tolerability and efficacy, all measurements are repeated at the end of the 12-week treatment period with CS1 and compared to baseline measurements and between doses. Including the follow up visit 2 weeks after the CS1 treatment period the total duration of the study is maximum 22 weeks.
For further information, please contact:
Josefine Göranson, Head of IR & Communication
Email: info@cerenoscientific.com
http://www.cerenoscientific.com/
This information is such that Cereno Scientific AB (publ) is required to make public in accordance with the EU's Market Abuse Regulation (MAR). The information was made public by the Company's contact person above on 4 April, 2023 at 08:30 CEST.
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 stable, selective, and potent prostacyclin receptor agonist. It 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 Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.