CombinatoRx has announced preliminary results of its randomized, blinded, placebo-controlled clinical trial of CRx-102 in patients with periodontitis, a chronic infectious/inflammatory disease associated with elevation of systemic inflammatory markers.
The trial was designed to determine how immunomodulating agents such as CRx-102 would affect various systemic inflammatory markers in individuals with periodontitis. In the primary endpoint of reduction in C-reactive protein (CRP) at day 42, CRx-102 demonstrated a statistically significant 0.65 mg/L decrease in CRP compared to placebo using a high sensitivity CRP analysis, representing a 16.7 percent reduction compared to a 0 percent reduction with placebo. CRx-102 did not appear to impact the secondary endpoint of periodontal pocket depth reduction. Analysis of the ability of CRx-102 to influence a panel of immuno-modulatory cytokines is ongoing.
CRx-102 contains a low dose of the steroid prednisolone and dipyridamole. CRx-102 was generally well-tolerated with the most common adverse events in the CRx-102 treated group comparable in nature and frequency to those in the placebo group. The most common adverse event in the study reported as related to CRx-102 was headache, a known side effect of dipyridamole.