Flexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta.
The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of the study’s 205 patients experienced clinical benefit 12 weeks after their first injection of Zilretta. 179 patients received a second dose of the drug between weeks 12 and 24, the company said.
Flexion reported that the average time to administration of the second dose of Zilretta was 16.6 weeks and that 74% of patients received their second administration between weeks 16 and 24.
The study enrolled patients who were previously treated with intra-articular corticosteroids and/or intra-articular hyaluronic acid therapy. 30.3% of participants had the most radiographically severe form of osteoarthritis.
“These results demonstrate Zilretta’s ability to provide deep and sustained relief to a patient population that reflects real-world clinical experience,” president & CEO Dr. Michael Clayman said in prepared remarks. “In particular, we are delighted to see an average time to second administration of greater than 16 weeks, which is especially notable given the high proportion of patients in this study with the most advanced stage of OA.”
Zilretta has been well-tolerated so far and researchers have not observed any drug-related serious adverse events, the company noted. Flexion is expected to report full results from the Phase III trial in the third quarter of 2018.
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