Anika Therapeutics announces strong patient response in CINGAL 16-02 trial
Anika Therapeutics announced results from its CINGAL 16-02 clinical trial, an active-comparator Phase III study being conducted to support U.S. registration. CINGAL has previously been evaluated in a placebo-controlled Phase III clinical trial that demonstrated safety and efficacy through 26-weeks. The 16-02 trial compared CINGAL, a combination of cross-linked HA and triamcinolone hexacetonide, with TH alone and cross-linked HA in treating patients with osteoarthritis in the knee. The primary endpoint was a comparison of the pain reduction of CINGAL compared with TH alone at 26-weeks. While CINGAL achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks did not reach statistical significance. The patient response to CINGAL in the study was strong, as significant improvements in pain, function, and quality of life were observed at levels consistent with, and in most cases greater than, the results of the 13-01 placebo-controlled Phase III study of CINGAL. A strong safety profile was also shown, matching previous clinical studies as well as real-world experience from growing product use globally. The duration of pain reduction was also similar to the previous study as patient improvement after CINGAL injection was maintained near peak levels throughout the 26-week duration of the study. Follow-up of patients continues in a prospectively designed extension phase to the study, which will gather data through 39-weeks.