Cereno Scientific reports an investigator-initiated patient case study from the ongoing Phase II study of CS1 in PAH

Cereno Scientific (Nasdaq First North: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced data received from a patient case study initiated by an investigator on the first patient having completed the Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) at the site. The case study is based on one patient and was performed to control the utility of CardioMEMS™ HF System (Abbott, Inc.), an innovative technology used to daily monitor pulmonary pressure and other cardiopulmonary function in patients in the study. Data indicates that drug candidate CS1 has a positive effect on pulmonary arterial pressure and cardiac function. It further indicates the utility of CardioMEMS in evaluating drug medication effectiveness in PAH.  

“We had initially no intention to perform and communicate any intermittent analysis of the study. The Clinical Steering Committee was, however, approached by an investigator in our clinical study with a request to perform a patient case study to evaluate the first patient having completed the study at this site based on a perceived health improvement of this patient over the study period. The Clinical Steering Committee decided to adhere to the investigator’s request. Upon reviewing the positive findings from this patient case study, we are further convinced of the utility of CardioMEMS in evaluating patients with PAH in our clinical study and the efficacy potential of our drug candidate CS1 in PAH patients,” said Björn Dahlöf, CMO at Cereno Scientific.

The patient in the case study was a 51-year-old female patient with symptomatic PAH for three years (NYHA/WHO functional class II) who was enrolled in the study. She had received maintenance treatment of tadalafil 40 mg, macitentan 10 mg, and treprostinil 32 μg dry powder inhaler. The CardioMEMS pulmonary artery (PA) Sensor was implanted in a distal branch of her PA following screening and she was randomized to the 1920 mg dose of CS1.

The findings of the case study, carried out during a 12-week treatment period with CS1, show that the patient’s mean pulmonal arterial (PA) pressure was reduced from 33 mmHg at baseline to 23 mmHg at the end of the period. Cardiac output was increased from 4.7 L/min at baseline to 5.6 L/min. Right ventricular (RV) stroke volume (SV) also increased when treated with CS1 over time, together with SV index and RV efficiency. These changes were accompanied by reductions in RV stroke work and total pulmonary resistance (TPR). The patient required no changes to her PAH medication during the study, and her status was improved from NYHA/WHO functional class II to functional class I at the end of the treatment period. There were no adverse events related to PA sensor implantation or the device itself and there were no serious adverse events reported on CS1.

In addition to the data related to the effects of CS1 in the PAH patient, the case study indicates that using the CardioMEMS PA Sensor permits safe daily remote monitoring of PA pressure over time in patients with PAH, permitting assessment of medication effectiveness on an individual patient level.

“Our clinical Phase II study is designed to include 30 patients to evaluate safety, tolerability, and exploratory efficacy of CS1 and the safety and utility of CardioMEMS in PAH patients. We look forward to seeing more patients being recruited and taking necessary steps to complete the study and report results around end of year. With these positive initial findings, we are optimistic about the Phase II study outcome and CS1’s potential. It is, however, important to stress that this is merely a one patient case study. Conclusions from the study and CS1’s potential will have to await the completion of the study and the subsequent analysis of the obtained data,” said Sten R. Sörensen, CEO at Cereno Scientific.

The Phase II study is currently actively recruiting patients. In mid-May, the company reported that 16 patients were enrolled in the study, 9 patients have received CardioMEMS HF System implantation, 5 patients were randomized and in active treatment, and 2 patients had completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated around year-end 2023.

For further information, please contact:

Jonas Fogelberg, Interim CFO
Email: info@cerenoscientific.com
http://www.cerenoscientific.com/

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 19.35 (CEST) on June 26, 2023.

About the Phase II study of CS1 in PAH

The Phase II study is ongoing to evaluate CS1’s safety and tolerability and efficacy in patients with the debilitating rare disease PAH. Hemodynamic assessment in patients with PAH is important for monitoring changes over time. Through a collaboration agreement with the global healthcare company Abbott, the pioneering technology the CardioMEMS™ HF System is used to daily monitor pulmonary pressure and other cardiopulmonary function in patients in the study. The primary objective of the study is to evaluate the safety and tolerability of the drug candidate CS1. All relevant standard endpoints used in previous PAH studies for this patient group will also be evaluated and a validated estimate of risk is calculated and various biomarkers, quality of life and various aspects of cardiac function.

As mentioned above, the case study is based on one patient and does not replace the analysis of the full data set of a completed study. The data should thus not be used to draw any conclusions on the safety and effectiveness of drug candidate CS1 in PAH. No other analyses will be made until the completion of the study with all 30 patients enrolled.

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.