The execs at Anika Therapeutics $ANIK struggled to find good things to say about their lead pipeline project’s Phase III study. But the failure to hit the key endpoint at 6 months for osteoarthritis did them in, driving their stock down by more than 25% after hours Tuesday.
Big improvements were tracked in pain function and quality of life compared to an earlier pivotal trial, researchers say. But that nagging flop for osteoarthritis of the knee at 26 weeks is what snared investors’ attention.
The drug is a combination of triamcinolone hexacetonide (TH), an FDA-approved steroid, with Anika’s hyaluronic acid. The second Phase III compared the combo against TH alone.
The biotech will set out to make the dubious claim that the pair of Phase III data should be enough to win an approval, but the skepticism was palpable Tuesday evening.
László Hangody, the global principal investigator of several CINGAL trials, said:
“While it has been observed that TH has a longer duration of effect than other corticosteroids, the results in this study were surprising. 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.”
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