Cereno Scientific AB announced that a new clinic has been activated in the ongoing Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH). The clinic is located in Austin, Texas, and starts recruiting patients immediately. The Phase II study is now actively running at 10 specialist clinics in the US with yet another new clinic currently in the late-stage start-up process.

The Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) is now actively recruiting patients at 10 specialist clinics in the US, and one additional new clinic is in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiac output.

The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result.

Currently, a request for expanded access to CS1 (also called "compassionate use") is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in second quarter of 2024.