Cereno Scientific shares progress update in the Phase II study with drug candidate CS1 in the rare disease PAH

Cereno Scientific (XSAT: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced an updated progress report of the Phase II study in pulmonary arterial hypertension (PAH) with drug candidate CS1. The study is proceeding well with currently 16 patients enrolled in the study, 9 patients having received CardioMEMS HF System implantation, 5 patients randomized and in active treatment, and 2 patients having completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated at year-end 2023.

“I am pleased that we are seeing continuous progress in the Phase II study with CS1 in PAH. I look forward to following the progress with more and more patients completing each of the different steps towards the completion of the study and analysis of the study results,” said Björn Dahlöf, CMO at Cereno.

“The team, together with our partner Abbot and our CRO, are working well with the participating clinics in the study to support steady advancements in patient recruitment as well as during the study period. The plan to report the study’s top-line results at the end of the year remains, bringing us closer to potentially being able to offer patients with PAH a new disease-modifying treatment. We are confident that our HDAC inhibitor CS1 has a game-changing potential providing patients with PAH a treatment that may reverse the disease progression, and hopefully prolong the lives of patients,” says Sten R. Sörensen, CEO at Cereno.

The Phase II study with CS1 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). Within two weeks after 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 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. In addition to the daily CardioMEMS measurements, all measurements are repeated at the end of the 12-week treatment period with CS1 and compared to baseline measurements and between doses to enable evaluation of CS1’s safety, tolerability, and exploratory efficacy. 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 prostacyclin receptor agonist and has 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.