Cardior Pharmaceuticals announced the dosing of the first patient in a multicenter phase II study evaluating the efficacy and safety of CDR132L in 280 patients after myocardial infarction (HF-REVERT). An antisense-like synthetic oligonucleotide is being used to control the regulatory microRNA miR-132.

Myocardial infarction (MI), 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 remodeling resulting in the development of heart failure. Heart failure remains one of the leading causes of death globally with only limited intervention options. Cardior’s lead candidate is designed to address the root cause of the pathological remodeling of the heart following MI to halt and reverse the detrimental signaling cascade and restore normal function of the heart. CDR132L is the first-ever ncRNA-based therapy to enter Phase 2 studies in heart disease.

CDR132L’s target is the well-established microRNA, miR-132, which plays a key role in pathological cardiac remodeling processes. Levels of miR-132 are elevated in the cardiac tissue of heart failure patients, triggering well-defined molecular pathways. Inhibition of miR-132 by CDR132L normalizes those pathways leading to a transformational change at the tissue level aiming to restore normal cardiac muscle function.

“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, MD, Chief Medical Officer of 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.”

The study will be conducted at locations across Europe involving approximately 60 clinical study centers. Cardior will initiate subsequent clinical trials for CDR132L in the U.S. following discussions with the U.S. Food and Drug Administration (FDA).

Last August, Cardior had raised over €64m in a Series B financing to fund this study. Investors included lead investor Inkef Capital and then-new co-investors Fund+, Sunstone, Hadean Ventures and Coparion. In addition, the old investors LSP (now operating under EQT Lifescience), BioMedPartners, Bristol Myers Squibb and High-Tech Gründerfonds (HTGF) participated.