Cereno Scientific has announced that a collaboration agreement has been entered with Abbott regarding use of its CardioMEMS HF System in the upcoming Phase II study with Cereno’s drug candidate CS1.
The technology will be used to remotely and continously monitor the pulmonary pressure in the Phase II study evaluating CS1 for the treatment of pulmonary arterial hypertension (PAH). The CardioMEMS device allows Cereno to use a smaller-sized patient population for the Phase II study, which is both more time and cost efficient, it states in a press release.
“We are passionate about innovation within cardiovascular disease treatment and are very pleased to now also be able to use a cutting-edge medical monitoring device such as Abbott’s. With their innovative CardioMEMS technology, we will be able to continuously monitor pulmonary pressure in the study participants which will help us to define the optimal dose range in following clinical development studies,” says Sten R. Sörensen, CEO at Cereno Scientific.
The Phase II study
The Phase II study intends to demonstrate drug candidate CS1’s safety, tolerability and exploratory efficacy in patients with the rare disease PAH. The primary endpoint is safety and tolerability. In addition, all standard efficacy endpoints for this patient group will be explored as well as a calculated validated risk score. Cereno anticipates that dosing for later studies will be informed by the continuous pulmonary pressure readings derived from the CardioMEMS HF System. The CardioMEMS HF System has already been proven, when managed by a physician, to significantly reduce heart failure hospital admissions and improve the quality of life for people living with NYHA Class III heart failure, describes the company in its press release.
The study will be conducted under the orphan drug designation (ODD) status awarded by the U.S. FDA at about six different U.S. clinical sites and 30 patients.
The study is planned to be initiated in September 2021 following acceptance from the U.S. FDA of the investigational new drug (IND) application prepared by both companies.