Organogenesis reports interim analysis of knee osteoarthritis trial

Organogenesis reported the outcome of the interim analysis of its Phase 3 clinical trial for the management of symptoms associated with knee osteoarthritis. The pre-specified interim analysis on 50% of the 474 required patients with moderate to severe knee osteoarthritis focused on the six-month primary endpoint for potential sample size re-estimation. The Independent Data Monitoring Committee, or DMC, for the trial provided directional guidance on the results of the interim analysis, while rigorously maintaining all aspects of study blinding. The DMC recommended that the trial proceed without modification and without increase to sample size. Additionally, the DMC found the safety data to be consistent with the known safety profile for ReNu. The fully enrolled 516 patient Phase 3 trial is a prospective, double-blind, multicenter, placebo-controlled, parallel group, randomized control trial, or RCT, of ReNu, a cryopreserved amniotic suspension allograft, or ASA, for the treatment of subjects with moderate to severe symptomatic knee osteoarthritis, or OA. Patients were randomized to receive a single intra-articular, or IA, injection of either saline control or ReNu. The primary endpoint is the reduction in knee pain assessed by the Western Ontario and McMaster Universities Arthritis Index, or WOMAC, pain scale performed on subjects treated with ReNu or saline. The number of knee replacement surgeries is growing every year and expected to rise from approximately 680,000 Americans in 2014 to 1.28M Americans in 2030.