Anika: Cingal 13-01 Study Meets Primary Endpoint

(RTTNews) - Anika Therapeutics Inc (ANIK) on Friday reported positive results from the Cingal 13-01 study that investigated the safety and efficacy of Cingal in treating pain in patients with osteoarthritis.

Cingal combines the cross-linked hyaluronic acid formulation of Monovisc, approved to provide long-term relief of the symptoms of osteoarthritis ("OA"), with an FDA-approved steroid to provide additional short-term pain relief.

In the study, 368 subjects were enrolled in a randomized, double blind, saline-controlled study with an active comparator arm (Monovisc). Results showed that Cingal is statistically and clinically superior to saline with the data meeting the primary and all secondary endpoints. Adverse event rates were very low, evidencing the safety of the product.

Cingal met the primary endpoint by demonstrating superiority over saline for the change in WOMAC Pain Score over baseline levels through 12 weeks after treatment in the Intent to Treat. The benefits proved long lasting as Cingal delivered a 72% improvement in WOMAC Pain Score relative to baseline at 26 weeks after injection.

The study results were included in pre-marketing applications submitted in the United States and European Union.

The company also said it has completed enrollment in the Cingal 13-02 study, a follow-on study to the Cingal 13-01 study, to assess the safety of a repeat injection of cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (Cingal) intended to provide symptomatic relief of OA of the knee.