US-based pharmaceutical firm Ischemix has enrolled the first patient in a Phase IIa trial of its lead compound CMX-2043 to prevent contrast-induced acute kidney injury (CI-AKI) in acute coronary syndrome patients undergoing coronary angiography (the CARIN trial).
CMX-2043 is a chemically-modified, naturally-occurring molecule with an excellent safety profile that has showed efficacy in a prior human clinical trial.
Brigham and Women’s Hospital Heart & Vascular Center Interventional Cardiovascular Programs executive director and CARIN trial lead investigator Deepak Bhatt said: "The CARIN trial presents an exciting opportunity to study the potential of CMX-2043 to treat cardiac patients who are at serious risk of complications."
Around 240 patients will be enrolled in the CARIN trial, which will evaluate the ability of CMX-2043 to prevent CI-AKI.
In the US, approximately 500,000 coronary angiography patients are at high-risk of developing CI-AKI and currently there are no approved drug therapies for the same.
The trial will also seek to confirm the results of its prior Phase IIa trial, where CMX-2043 prevented peri-procedural cardiac injury in patients undergoing a percutaneous coronary intervention (PCI).
Ischemix intends to announce data from the CARIN trial in mid-2015, when it plans to initiate discussions with prospective corporate partners.
The company believes that CMX-2043 has the opportunity to address indications with in excess of a billion dollars of potential revenues, while producing a net cost savings to the health care system.