CMC Contrast AB is a privately owned drug development company developing CMC-001, a novel contrast agent for diagnostic use in MRI of the liver of patients in whom use of gadolinium based contrast agents is medically inadvisable due to the risk of serious side effects such as Nephrogenic Systemic Fibrosis.
A liver MRI scan is a specialized radiology procedure used to examine the liver to identify certain conditions or diseases which can be malignant or benign lesions. A liver scan may also be used to follow the progress of treatment of certain conditions. For most patients a contrast agent containing a gadolinium chelate is administered intravenously to improve the diagnostic value of the liver MRI.
However, a small patient subset cannot tolerate or should not be administered a gadolinium chelate as described in their package inserts and according to guidelines applied by regulatory authorities such as FDA and EMA. Currently, this subset of patients can only be examined by unenhanced MRI. The unenhanced MRI is known to be inferior to contrast enhanced MRI, and consequently this subset of patients would benefit from a contrast enhanced MRI using CMC-001 to improve detection and localization of lesions in the liver to support decision making for further medical intervention and disease management.
CMC Contrast AB is committed to develop CMC-001 to allow radiologists to perform contrast enhanced liver MRI for this patient population and thus become an important tool for clinicians to improve detection and localization of focal lesions of the liver. CMC-001 is the first contrast agent in the world to obtain Orphan Drug Designation by the FDA for use in liver MRI in patients where use of gadolinium-based contrast agents may be medically inadvisable or where gadolinium-based contrast agents cannot be administered.
Phase I and II clinical studies have been completed with CMC‑001 and preparations for a pivotal phase III clinical program are ongoing.
CMC Contrast AB holds global commercial rights to CMC-001.
CMC Contrast AB is based in Malmö, Sweden, and funded by prominent VC investors including Sunstone Capital and Øresund Healthcare.