Anika's osteoarthritis pain drug falls short at Phase 3

Anika Therapeutics has become the latest in a recent string of firms to suffer a failure in a late-stage trial, with its cross-linked hyaluronic acid (HA) and triamcinolone hexacetonide (TH) combination Cingal failing to meet its primary endpoint of pain reduction in knee osteoarthritis patients compared to TH alone after 26 weeks.

The company noted that Cingal did achieve a greater pain reduction at every time point throughout the study, but after 26 weeks this was not enough to be considered statistically significant.

"While it has been observed that TH has a longer duration of effect than other corticosteroids, the results in this study were surprising," commented Professor Laszlo Hangody, the global principal investigator of several Cingal trials. "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."

Anika’s shares were rocked by the news, falling as much as 20%. Cingal has already secured approval in Europe as a replacement for synovial fluid in human joints, and for the treatment of pain in knee osteoarthritis in patients have not responded to conservative non-pharmacologic therapy and to simple analgesics.

Anika President and CEO Joseph Darling also remarked: "OA patients continue to benefit from the proven safety and efficacy of Cingal in growing numbers outside of the US where Cingal is approved. The benefits of combining HA and a corticosteroid are mirrored by 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. 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 US regulatory approval of Cingal. We remain fully committed to bringing this impactful OA solution to US patients and physicians."