Cereno Scientific reports progress with its CS1 Phase II study in PAH: all study sites are activated and top-line results are expected end of 2023
Cereno Scientific (XSAT: CRNO B) today announced that all clinical sites are activated and actively recruiting patients in the ongoing Phase II study in the rare disease pulmonary arterial hypertension (PAH) with the drug candidate CS1. To date, three patients have been randomized and entered the treatment period. The study’s top-line results are now expected by end of 2023.
“It is great to finally see all 9 clinical sites in the study activated in January and recruiting after an unforeseen extended start-up and activation phase. As previously communicated, during fall and winter we worked hard on trying to activate centers and implemented different measures to simplify and increase the patient recruitment, including a study protocol amendment submitted to the FDA which was effective on January 24. We are now starting to see the real effect of these initiatives. The amended study protocol has been well received by the investigators, and we are now seeing a significant increase in the number of patients identified for screening and potential inclusion in the study. We foresee that our target to enrolling 30 patients who meet the inclusion criteria are being recruited into the study in the coming months,” says Björn Dahlöf, Chief Medical Officer (CMO) at Cereno.
The Phase II study in the rare disease PAH with drug candidate CS1 has received much recognition for its innovative design. In March 2020, Cereno received the US FDA’s orphan drug designation (ODD) for the clinical development program for CS1 in PAH. Through the granted ODD, the FDA has indicated that they believe CS1 has the potential to provide significant benefit to patients suffering from PAH.
The patient recruitment starts with the patient undergoing a screening process. After right heart catheterization, implantation of the CardioMEMS HF System takes place to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After 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 evaluated. To enable exploration of CS1’s efficacy, measurements are repeated at the end of the 12-week treatment with CS1 and compared to baseline and between doses.
“The unmet medical need for patients with PAH is tremendous. We believe our drug candidate CS1 has the very highly sought-after potential to reverse the progression of PAH, and not only alleviate the symptoms as is the case with today’s available drug treatments. CS1 has a disease modifying potential to improve both patient quality of life and prolong life expectancy. The impact the lingering covid-19 pandemic in the US has had on the study’s start-up timeline, does not reduce our drive to pursue a better treatment option for patients and their families affected by PAH. The ongoing Phase II study with CS1 in PAH has the potential to make a major difference in the future treatment landscape,” says Sten R. Sörensen, CEO at Cereno.
In September 2021, the FDA accepted an investigational drug application (IND) to start the Phase II multi-center PAH study in the US. Since then, many activities and processes have been executed culminating in the recent activation of all clinical sites participating in the study and the acceptance by FDA of change in eligibility criteria.
For further information, please contact:
Josefine Göranson, Head of IR & Communications
Phone: +46 704 92 35 63
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 14 February 2023 at 13:30 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 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. Drug candidate CS014 is a novel HDAC inhibitor with epigenetic effects. In preclinical studies it has been documented to regulate platelet activity, fibrinolysis and clot stability 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.