The HF-REVERT study is evaluating efficacy and safety of heart failure therapy
Cardior has announced the dosing of the first patient in their multicentre phase 2 trial assessing efficacy and safety of CDR132L in 280 patients with reduced left ventricular ejection fraction after myocardial infarction (MI).
CDR132L is an oligonucleotide-based ncRNA inhibitor that targets microRNA-132, a central regulator of pathological cardiac remodelling processes. Cardiac remodelling is a debilitating and often life-threatening consequence of myocardial infarction that contributes to the development of heart failure.
Myocardial infarction, commonly known as a heart attack, is an extremely severe condition caused by a blockage in the coronary arteries limiting the blood supply to the heart. Even if resolved, MI can lead to permanent damage of the heart cells initiating pathological cardiac remodelling, resulting in the development of heart failure.
Meanwhile, heart failure remains one of the leading causes of death globally with only limited intervention options available. Cardior’s lead candidate is designed to address the root cause of the pathological remodelling of the heart following MI to halt and reverse the detrimental signalling cascade and restore normal function of the heart. CDR132L is the first-ever non-coding RNA(ncRNA)-based therapy to enter phase 2 studies in heart disease.
“RNA therapies have a tremendous potential to fundamentally change the treatment paradigm for many diseases. Achieving phase 2 initiation for CDR132L marks a meaningful step towards validating a disease-modifying therapeutic that inhibits a master regulator of cardiopathology. This innovation is based on our in-depth expertise in developing non-coding RNA-based treatments,” said Rahul Agrawal, chief medical officer at Cardior.
“Our antisense oligonucleotide-based inhibitor addresses key molecular mechanisms to prevent or reverse heart failure following myocardial infarction and we look forward to documenting the impact it can provide to improve patients’ quality of life and reduce mortality,” he added.
The HF-REVERT study consists of a six-month double-blind period and a six-month extension period. Patients enrolled in the phase 2 study will be randomised to receive three intravenous CDR132L infusions at either 5mg/kg, 10 mg/kg or placebo, administered 28 days apart as an add-on to standard of care treatment.
