Cereno Scientific (XSAT: CRNO B) today reported that the first patient has been enrolled in the Phase II study in pulmonary arterial hypertension (PAH) with drug candidate CS1. Based on the timing of enrollment and several factors mainly related to the activation of clinical sites, the study timeline has been adjusted by about a quarter and top-line results are now estimated for Q1 2023. The number of study sites has been increased to include about 10 clinics across the US with potential for further expansion in order to facilitate meeting the Q1 timeline.
“It is great to have the first PAH patient enrolled in our Phase II study. We had originally expected about six months from IND acceptance to the first patient enrolled in the study. The lingering covid-19 pandemic in the US has affected our Phase II study start-up timeline through prolonged contracting due to staff shortages at the study’s clinical sites as well as extended processing time to obtain approvals from local boards and ethical committées. We are happy to see great interest from the study sites and excitement from the clinics having started active patient recruitment. Having the first patient enrolled signifies a significant milestone in our progress towards demonstrating that our drug candidate CS1, with its unique efficacy profile, has the potential to offer a safe, efficacious, and disease-modifying treatment option for patients suffering from the severe rare disease PAH,” says Sten R. Sörensen, CEO at Cereno Scientific.
Björn Dahlöf, Chief Medical Officer (CMO) at Cereno Scientific, comments “We are very pleased with the interest we have received from specialist clinics in the US to participate in our innovative Phase II study with our collaborative partner Abbott that provides the cutting-edge technology CardioMEMS to monitor cardiopulmonary hemodynamics. I am happy to see that patient enrollment has started and look forward to a good and timely recruitment process of all the 30 patients as we move forward.”
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. In September 2021, an investigational drug application (IND) was accepted by the FDA to start a Phase II multi-center PAH study in the US. Since then, many activities and processes have been executed culminating in the activation of clinical sites participating in the study and the subsequent patient enrollment.
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