Anika Therapeutics: Positive Results for Knee OA Therapy

Anika Therapeutics, Inc., following up on the success of its CINGAL 13-01 trial for knee osteoarthritis (OA), is announcing that CINGAL 13-02 has also been a home run. The study evaluated the safety of a repeat injection of CINGAL for symptomatic relief of knee OA. According to Anika Therapeutics, CINGAL is made up of its proprietary cross-linked sodium hyaluronate (MONOVISC) with an FDA-approved steroid, triamcinolone hexacetonide.

“CINGAL is poised to be the first injectable viscosupplement that combines the proven benefits of our proprietary hyaluronic acid formulation with a well-established steroid to effectively treat the symptoms associated with osteoarthritis of the knee, ” said company President and Chief Executive Officer Dr. Charles H. Sherwood in the July 9, 2015 news release. “The results of this follow-up study combined with our initial Phase 3 data suggest that CINGAL maintains a consistently strong safety profile in both an initial injection as well as a repeat injection.”

For this study, the company enrolled 242 patients who had been involved in the CINGAL 13-01 study. The CINGAL 13-02 study participants received an open-label injection of CINGAL. The team found that 6.2% of patients had an adverse event related to the study injection.

“Observed AEs [adverse events] were typical of those associated with viscosupplements (arthralgia, injection site pain, swelling, and erythema), and over 95% were considered ‘mild’ or ‘moderate’ in severity. All AEs were transitory, resolving naturally without treatment. The AE rate associated with CINGAL was found to be consistent across both first-time and repeat injection studies. There were no statistically significant differences between the AE profile of participants in the CINGAL 13-01 study (single injection) and those in the CINGAL 13-02 study (repeat injection).”

A company representative told OTW, “There are several aspects about CINGAL and this particular study that orthopedic surgeons will find interesting. First of all, a strong outcome from the pivotal study announced earlier this year, combined with the good retreatment safety results in this study demonstrate the efficacy of CINGAL, and suggest that CINGAL maintains a consistently strong safety profile whether it’s given as an initial injection or as a repeat injection. These findings are significant to physicians who manage patients with a chronic, degenerative disease like osteoarthritis where repeat treatment may be needed to achieve optimal pain relief.

“CINGAL is poised to be the first viscosupplement that combines two well-established and FDA-approved treatments for osteoarthritis of the knee: hyaluronic acid, which is found in currently available viscosupplement MONOVISC, and triamcinolone hexacetonide, a steroid currently used to manage OA knee pain and inflammation.”

“As CINGAL continues to advance toward commercialization, we see potential for international revenue from CINGAL beginning in 2016, and we are working toward achieving U.S. approval before the end of 2016.”