Shares of Bedford, Mass.-based Anika Therapeutics have plunged more than 20 percent in premarket trading.
Shares of Bedford, Mass.-based Anika Therapeutics have plunged more than 20 percent in premarket trading after the company announced its Phase III knee osteoarthritis study failed to meet endpoints.
Anika said its CINGAL product for knee osteoarthritis did not achieve statistical significance at primary endpoint of 26 weeks in active comparator study. While CINGAL, a combination of cross-linked hyaluronic acid (HA) and triamcinolone hexacetonide (TH), achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks did not reach statistical significance when compared with triamcinolone hexacetonide alone, the company said late Tuesday. 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.
In a previous placebo-controlled 13-01 Phase III trial, Anika said CINGAL demonstrated safety and efficacy through 26 weeks. With the efficacy demonstrated in the previous Phase III trial and the other data from the 16-02 trial that did not achieve statistical significance, Anika plans to work closely with regulators at the U.S. Food and Drug Administration (FDA) to gain approval.
The patient response to CINGAL throughout the study was strong, the company said. Anika noted that patients saw 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.
The company does intend to complete a three-month follow-up extension phase of the study will continue.
Cingal has been approved for use outside the United States. Joseph Darling, president and chief executive officer of Anika, said osteoarthritis patients who use approved Cingal in other markets
continue to benefit from the proven safety and efficacy of CINGAL.” Darling noted that the benefits of combining hyaluronic acid and a corticosteroid have been expressed through physician feedback and “real-world experience.”
“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 three-month extension study,” Darling said in a statement. “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.”
Lazlo Hangody, the global principal investigator of multiple CINGAL trials, concurred with Darling about the overall efficacy of CINGAL. Despite the failure of statistical significance in comparison to triamcinolone hexacetonide alone, Hangody said the patient response to CINGAL was strong. Patients “received statistically and clinically meaningful rapid and long-lasting improvement in symptoms compared with base-line,” Hangody said. That relief was consistent with the previous study.
“Taken together, the results of the two Phase III studies validate the effectiveness of this novel combination for use in patients with knee osteoarthritis,” Hangody said.
