Cereno Scientific and Abbott enter collaboration for use of cutting-edge monitor device in upcoming Phase II study with CS1
Cereno Scientific (XSAT: CRNO B) today announced that a collaboration agreement has been entered with global healthcare company 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.
“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,” said Sten R. Sörensen, CEO at Cereno Scientific.
“Patients with primary pulmonary hypertension -WHO Group 1– are particularly difficult to medically manage, especially without feedback from pulmonary pressures. The collaboration with Cereno is very exciting with hopes of clarifying and improving outcomes in PAH,” said Philip Adamson, M.D., chief medical officer for Abbott’s heart failure business. ”By using CardioMEMS this clinical study provides a unique opportunity to examine the potential benefits of pulmonary artery pressure monitoring and possibly improve the paradigm of medical management in this group of patients.”
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.
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. Dr. Raymond Benza, a global thought-leader in PAH and part of Cereno’s scientific advisory board, will be the principal investigator (PI) of the study. 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.
For further information, please contact:
Daniel Brodén, CFO
Phone: +46 768 66 77 87
Email: info@cerenoscientific.com
http://www.cerenoscientific.com/
About Cereno Scientific AB
Cereno Scientific is a clinical stage biotech company within cardiovascular diseases. The lead drug candidate, CS1, is a Phase II candidate in development for the treatment of the rare disease pulmonary arterial hypertension (PAH) and thrombotic indications. CS1 is an HDAC (Histone DeACetylase) inhibitor that acts as an epigenetic modulator with anti-thrombotic, anti-inflammatory, anti-fibrotic and pressure-relieving properties, all relevant for PAH. A clinical phase II study for CS1 in PAH is expected to be initiated in September 2021 under its US FDA granted orphan drug designation (ODD) status. In addition, Cereno has two promising preclinical development programs targeted at treating cardiovascular diseases. The company is headquartered in AstraZeneca’s BioVenture Hub, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.