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 0.65mg/L decrease in CRP, compared to placebo, representing a 16.7% reduction compared to no reduction with placebo.
CRx-102 did not appear to impact upon 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 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, which CRx-102 contains.
“CRx-102 is clearly active both immunologically as shown in this human inflammatory model and clinically as demonstrated by the previously announced positive phase II data in patients with hand osteoarthritis,” commented Alexis Borisy, president and CEO of CombinatoRx. “We look forward to presenting additional phase II data on CRx-102 during the year.”