Anika Therapeutics has reported negative top-line data in the 16-02 trial, a Phase III clinical study evaluating Cingal to treat patients with osteoarthritis (OA) in the knee.
The placebo-controlled trial compared Cingal with triamcinolone hexacetonide (TH) alone and cross-linked HA among the enrolled patients.
Its primary endpoint includes a comparison of the pain reduction of Cingal compared with TH alone at 26 weeks.
The trial found that Cingal achieved greater pain reduction numerically at every time point in the study, but the difference at 26 weeks did not reach statistical significance.
It also showed significant improvements in pain, function, and quality of life of the patients, as well as a strong safety profile of Cingal.
Anika is currently following up the patients in a prospectively designed extension phase of the trial, which will collect data through 39 weeks.
The company, however, expects to work with the regulators to receive US approval to register Cingal in the country.
Cingal trials global principal investigator Laszlo Hangody said: “While it has been observed that TH has a longer duration of effect than other corticosteroids, the results in this study were surprising.
“Nevertheless, the patient response to Cingal in this study was strong as patients received statistically and clinically meaningful rapid and long-lasting improvement in symptoms compared with base-line, consistent with the previous study as well as my experience in my practice.
“Taken together, the results of the two Phase III studies validate the effectiveness of this novel combination for use in patients with knee osteoarthritis.”
Cingal is a combination of cross-linked HA and TH. It is designed to provide rapid and long-lasting relief from pain and discomfort caused by OA.