Cereno Scientific’s Phase II study in the rare disease PAH reports two patients successfully completed the treatment period with drug candidate CS1
Cereno Scientific (XSAT: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced that two patients have successfully completed the treatment period in the study. The study is proceeding according to plan and top-line results are anticipated at year-end 2023.
“We are happy to see further progress in the Phase II study with CS1; recruitment is still a major focus, however, equally important is that patients are able to successfully complete the study treatment period with CS1,” Björn Dahlöf, CMO at Cereno.
“I am pleased with the progress in the study and anticipate that we can keep a steady pace through to the end of recruitment this summer. CS1 is a drug candidate with significant potential to offer a disease-modifying treatment alternative for people living with the devastating disease PAH,” says Sten R. Sörensen, CEO at Cereno.
The Phase II study is divided into several important steps from beginning to end to ensure high-quality data from the study. The patient recruitment begins with each clinic identifying and pre-screening patients using the clinic's patient registries and study physicians’ knowledge about their patients. The patients that fulfill all inclusion criteria and none of the exclusion criteria are scheduled for a first visit where patients consent to participation in the study and all criteria are confirmed. If all checks out, the patient is considered to have started the study (i.e., been recruited into the study with a successful screening visit). About two weeks post the first visit, the patient is subjected 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 further four to six 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. The 30 patients are randomized to one of three dose groups of CS1, and 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. The study's total duration is a maximum of 22 weeks, including the follow-up visit two weeks after the treatment period.
For further information, please contact:
Jonas Fogelberg, Interim CFO
Email: info@cerenoscientific.com
http://www.cerenoscientific.com/
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.