CMX-2043 has achieved preclinical proof of concept in a first set of studies using two models (focal and diffuse) of TBI. This first set of preclinical 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 a second set of three studies in another preclinical model of TBI. Significant increase microstructural integrity of brain tissue, improvement in levels of brain metabolites, upregulation of mitochondrial energetics and 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.
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.
In 2023 a two-part, double-blinded, randomized, placebo-controlled Phase 1 trial was successfully completed in which single ascending doses (SAD) of CMX-2043 were administered by brief intravenous infusion to 40 healthy male and female subjects. After completion of the SAD portion of the trial, 40 additional healthy male and female subjects were randomized to receive multiple ascending doses (MAD) of CMX-2043 or placebo by daily intravenous infusion for five days.
