Cereno Scientific announced on January 31, 2024 that it has received approval from the US Food and Drug Administration (FDA) for expanded access to the investigational drug CS1 in the ongoing Phase II trial for pulmonary arterial hypertension (PAH). This program allows patients who completed the Phase II to continue CS1 therapy. Positive outcomes from the study prompted the FDA approval, with the expanded access program providing an opportunity for long-term safety and efficacy data collection.
The drug CS1 has important anti-inflammatory, anti-fibrotic, and anti-thrombotic properties, which may be advantageous in pulmonary arterial hypertension.
CS1 has shown promising results in pulmonary arterial hypertension patients, with notable improvements in pulmonary pressure and cardiac output. The Phase II study is ongoing and carried out in collaboration with Abott, and a scientific board of prominent people in the field such as Dr Raymond Benza and Dr. Deepak Bhat, with top-line results expected in Q2 of 2024.
Read more about the study at this link in the January 2024 issue of “Pulmonary Circulation” and this link on the clinicaltrials.gov website
This is the link to the press release on the Cereno Scientific website.
Citation
Pulmonary Circulation ,vol14, issue 1 L. Benza, Philip B. Adamson, Deepak L. Bhatt, Fredrik Frick, Gunnar Olsson, Niklas Bergh, Björn Dahlöf, First published: 03 January 2024 https://doi.org/10.1002/pul2.12323