Flexion enrolls first patient in Phase 3 trial of ZILRETTA

Flexion Therapeutics announced that, on December 26, 2018, the first patient was enrolled in a Phase 3 clinical trial to evaluate the safety and efficacy of ZILRETTA in patients with hip osteoarthritis. Similar to knee OA, hip OA is a degenerative disease which has no cure, and it is estimated that roughly 25% of the U.S. population may develop symptomatic hip OA in their lifetime. The initiation of the Phase 3 hip registration trial was supported by findings from a Phase 2, randomized, open-label, pharmacokinetic study in the shoulder and hip joints, known as the SHIP study. The results from the SHIP study demonstrated that ZILRETTA was generally safe and well tolerated, and the PK profile of ZILRETTA observed in both joints was consistent with previous PK studies in the knee. Results also showed that an injection of ZILRETTA into the hip resulted in 6-fold lower peak plasma levels and reduced systemic exposure compared to immediate-release triamcinolone acetonide in crystalline suspension. The data on the hip cohort have been submitted for presentation. https://thefly.com/landingPageNews.php?id=2842805