CMX-2043 has achieved preclinical proof of concept in two models (focal and diffuse) of TBI. These studies demonstrated the compound’s ability to confer significant improvement vs controls in sensorimotor activity, and in cognitive endpoints of learning and memory.
The product candidate has also established proof of concept in three studies in another preclinical model of TBI. Significant reduction in brain lesion size, improvement in levels of brain metabolites, upregulation of mitochondrial energetics, reduction of reactive oxygen species in treated subjects versus controls were demonstrated.
Proof of concept in improvement in post-TBI behavior using actigraphy technology was also demonstrated by CMX-2043. The candidate is the first therapeutic to be studied for, and to show significant behavioral benefits in, this particular model of TBI.
CMX-2043 has also shown significant benefit in a preclinical model of ischemic stroke and in a preclinical model of global ischemia.
Previously, CMX-2043, successfully completed a Phase 1 safety trial in healthy volunteers and a 142-patient Phase 2a trial demonstrating prevention of cardiac injury in PCI patients. In a 360-patient Phase 2 trial (CARIN), CMX-2043 demonstrated safety but did not meet pre-specified endpoints regarding prevention of contrast-induced acute kidney injury (CI-AKI) or cardiac injury in cardiac catheterization lab subjects.