This phase 3 study was testing Anika's drug Cingal -- which is a combination of cross-linked hyaluronic acid (HA) and triamcinolone hexacetonide (TH) that is approved in Europe -- in comparison to TH alone treating patients with osteoarthritis (OA) in the knee. The primary endpoint of the 26-week study was to show a reduction in pain.
Unfortunately, the results failed to show that using Cingal led to a statistically significant reduction in pain.
Anika Therapeutics announces that CINGAL 16-02 clinical trial for knee osteoarthritis did not achieve statistical significance
Co announces 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.
Co states, "...While we expected CINGAL to perform as well as it did, we were surprised that the difference in pain reduction seen in this trial did not reach statistically significant levels at six months. We will however, continue to monitor the results of the ongoing 3-month extension study. We are actively reviewing the data and our plan is to work closely with regulators to come to an understanding of the next steps required to gain U.S. regulatory approval of CINGAL. We remain fully committed to bringing this impactful OA solution to U.S. patients and physicians."
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