Preliminary analysis showed that MLN1202 was well tolerated and fully met its primary endpoint of a significant reduction in C-Reactive Protein (CRP) levels, an inflammatory biomarker associated with atherosclerosis, for months after a single dose of MLN1202.
These results were statistically and clinically significant relative to the placebo control arm. No serious adverse events were observed in patients exposed to MLN1202.
The phase II clinical trial enrolled 108 patients who were at high risk for atherosclerosis and had documented elevations in CRP.
“The sustained activity of MLN1202 on CRP as seen in this trial of patients at high-risk for atherosclerosis offers potential for anti-inflammatory activity in the treatment of coronary artery disease,” said Dr Eugene Braunwald, chairman, TIMI study group, Brigham and Women's Hospital.
“Well-documented clinical studies suggest that successful prevention and treatment of coronary atherosclerosis supports monitoring of inflammation as well as cholesterol. These studies further suggest that statins alone may not be sufficient in the treatment of all patients,” continued Dr Braunwald.