- Shares in Massachusetts-based Anika Therapeutics fell in value by nearly a third Wednesday, sparked by news the company's treatment for pain related to osteoarthritis of the knee fell short of its goal in a Phase 3 study.
- The therapy Cingal, which combines a lubricating gel with a corticosteroid into a single injection, failed to statistically outperform the two components given separately. Anika was quick to note that the compound did lead to a numerically greater reduction in pain at all time points.
- "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," said company CEO Joseph Darling in a June 19 statement.
Despite Anika's efforts to tout Cingal's efficacy, investors were not pleased with the Phase 3 miss. Market reaction to the news, which was announced after trading closed Tuesday, shaved more than $200 million off of the regenerative medicine company's market capitalization.
It's a rough welcome to the job for Darling, who was named CEO in March.
"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," Darling said.
Cingal is already approved in Europe and Canada. Anika had hoped to secure an OK from the Food and Drug Administration by the middle of next year.
That could now be in doubt after Cingal came up short in the late-stage trial, which tested the combination treatment's effect on reducing pain from osteoarthritis of the knee over 26 weeks. The results experienced by patients in the treatment arm were comparable to those seen in Anika's previous Phase 3 study, which compared Cingal to placebo.
Yet Cingal's inability to beat out an active comparator could raise questions about the treatment's profile. Cingal pairs Anika's cross-linked hyaluronic acid, a vicosupplement, with triamcinolone hexacetonide, a steroid.
Safety results matched those observed in other clinical studies and real-world use of Cingal outside the U.S., Anika said.
Follow-up of patients tested in the trial will continue for another three months as part of a prospectively designed extension study, Anika said.
The setback comes as Anika deals with the effects of a decline in revenues from its older Orthovisc product and a $1.1 million charge related to voluntary recalls of three hyaluronic acid-based treatments.
Over the first three months of the year, product sales declined 9% to $21.3 million.