Flexion announces initial data from trial for repeat administration of Zilretta
Flexion Therapeutics announced initial findings from its ongoing Phase 3b, open-label study to evaluate the repeat administration of Zilretta in patients with osteoarthritis, or OA, of the knee. The data show that of the 205 evaluable patients enrolled in the study, 95% experienced clinical benefit by Week 12 following the initial injection of Zilretta, as determined by self-assessment and with the agreement of their physician. Furthermore, to date 90% of eligible patients have received a second dose of Zilretta between Weeks 12 and 24, with three patients still pending repeat administration. "These data are very encouraging and provide us with the first glimpse of how Zilretta can perform in a real-world setting," said Michael Clayman, M.D., President and CEO of Flexion. "In particular, we are pleased with the observation that the vast majority of patients have experienced clinical benefit and that so many of them elect to have a second injection." The primary endpoint of the trial is overall safety and general tolerability of repeat administration of Zilretta in patients with symptomatic OA of the knee. Participants received an initial intra-articular injection of Zilretta followed by evaluation at Weeks 12, 16, 20 or 24 to determine their eligibility for a second injection. Repeat administration occurred when, in the opinion of the patient and physician, the patient benefited from and tolerated the initial administration without safety concerns and was clinically indicated to receive additional treatment.