Cereno Scientific 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, 6 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.

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.