Ischemix is pleased to announce that it has successfully enrolled the first patient in a Phase 2a trial of its lead compound to prevent contrast-induced acute kidney injury ("CI-AKI") in acute coronary syndrome patients undergoing coronary angiography (the "CARIN" trial). The Company's lead compound, CMX-2043, is a chemically-modified, naturally-occurring molecule with an excellent safety profile that has demonstrated efficacy in a prior human clinical trial.
"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," stated Dr. Deepak L. Bhatt, lead investigator of the CARIN trial. Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart & Vascular Center, and Professor of Medicine at Harvard Medical School.
The CARIN trial will enroll 240 patients to study the ability of CMX-2043 to prevent CI-AKI. It is estimated that approximately 500,000 coronary angiography patients each year in the US are at high risk of developing CI-AKI. Overall, an estimated 7 to 10 million patients receive contrast media in the US each year. There are no drug therapies approved for CI-AKI. The CARIN trial will also seek to confirm the results of its prior Phase 2a trial in which CMX-2043 prevented peri-procedural cardiac injury in patients undergoing a percutaneous coronary intervention ("PCI"). There are an estimated 600,000 PCI procedures in the US each year.
Ischemix estimates that data from the CARIN trial will be available in mid-2015, at which time the Company plans to initiate discussions with prospective corporate partners. Ischemix 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.