Cereno, Abbott Team Up to Measure Lung Blood Pressure in New Trial
Cereno Scientific is planning to begin a Phase 2 clinical trial of CS1 — the company’s lead therapy candidate for pulmonary arterial hypertension (PAH) — this September, following clearance from the U.S. Food and Drug Administration (FDA).
The upcoming trial will use Abbott‘s CardioMEMS HF System, a wireless, implantable monitor that continuously measures pulmonary arterial pressure, or the blood pressure in the arteries of the lungs, per a new agreement between the two companies.
“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,” Sten R. Sörensen, Cereno’s CEO, said in a press release.
“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,” Sörensen said.
Using CardioMEMS will allow the trial to enroll fewer participants, which is more efficient in terms of both cost and time, according to Cereno. Prior research has suggested that the FDA-approved monitor can measure changes in blood flow and help to predict the risk of heart failure in people with PAH.
Moreover, the technology will be used remotely.
“Patients with primary pulmonary hypertension — WHO Group 1 — are particularly difficult to medically manage, especially without feedback from pulmonary pressures,” said Philip Adamson, MD, chief medical officer for Abbott’s heart failure business.
“The collaboration with Cereno is very exciting with hopes of clarifying and improving outcomes in PAH,” Adamson said.
“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,” he added.
CS1 is a reformulation of valproic acid, an anti-seizure medication that has long been used as a treatment for epilepsy. It works by blocking the activity of histone deacetylase (HDAC), an enzyme that makes chemical modifications that change how DNA is “read.”
By blocking HDAC — and, consequently, changing the genetic activity within the cell — CS1 is thought to have anti-clotting, anti-inflammatory, anti-scarring, and pressure-relieving properties, all of which may be therapeutically beneficial in PAH. The investigational therapy was recently designated an orphan drug by the FDA.
The upcoming Phase 2 trial aims to enroll 30 participants with PAH at about six clinical sites in the U.S. The study’s main goal is to assess safety and tolerability; efficacy-related goals also will be measured.