CMC-001 is an investigational new drug for diagnostic use as a MRI contrast agent for enhancement of the liver. The compound is being developed for use in patients who cannot or should not be administered gadolinium based contrast agents. It is the first contrast agent in the world, to obtain Orphan Drug Designation by the FDA for use in liver MRI in patients who are contraindicated or cannot be administered gadolinium-based contrast agents.
CMC-001 is orally administered and consists of manganese combined with uptake promoters (manganese (II) chloride tetrahydrate (with L-alanine and vitamin D3 as promoters of absorption)). Manganese is a natural trace element and after absorption from the gastrointestinal tract is efficiently taken up by liver hepatocytes. Due to the retention of manganese in the hepatocytes and its paramagnetic properties the contrast agent clearly enhances the liver tissue in MR imaging. From the liver the manganese is excreted via the bile. CMC-001’s route of administration, uptake and excretion means that only minute amounts of manganese enter the systemic circulation.
The currently used MRI contrast agents are based on gadolinium and have been associated with Nephrogenic Systemic Fibrosis in patients with severely impaired kidney function. Consequently, regulatory authorities have contraindicated the use of these contrast agents in patients with eGFR <30 ml/min/1.73 m2 as well as in Acute Kidney Injury patients. These patients are candidates for CMC-001.
CMC Contrast is currently planning a pivotal clinical program with CMC-001 to obtain regulatory approval and make CMC-001 available to patients who are contraindicated or cannot be administered gadolinium-based contrast agents.