Organogenesis provides update on Phase 3 trial of ReNu in knee osteoarthritis

Organogenesis (ORGO) announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft – ASA -, for the management of symptoms associated with knee osteoarthritis. The pre-specified interim analysis on 50% of the planned 474 patients with moderate to severe knee OA focused on the 6-month primary endpoint for potential sample size re-estimation. The Data Monitoring Committee 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 594 patient Phase 3 trial is a prospective control trial of ReNu ASA, for the treatment of subjects with moderate to severe symptomatic knee OA. Patients were randomized to receive a single intra-articular injection of either saline control or ReNu. The primary endpoint is the reduction in knee pain.