Press release
Organogenesis Reports Positive Interim Analysis of Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis
CANTON, Mass. , March 01, 2023 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the
About this update from Organogenesis Holdings Inc.
[{"type":"text","content":"CANTON, Mass. , March 01, 2023 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today reported the favorable 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 (Kellgren-Lawrence [KL] severity grade 2 to grade 4) focused on the 6-month primary endpoint for potential sample size re-estimation. The Independent Data Monitoring Committee (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. “We are very pleased with the outcome of the interim analysis,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “Based on these statistical results in the favorable zone, we believe the positive clinical results for pain reduction predicted before the start of our pivotal trial are more likely. The assumptions for the statistical modeling and sample size of the trial were based on the successful, published two hundred patient trial.” Eric Strauss, MD, Professor of Orthopedic Surgery at NYU Langone Medical Center, and Co-Principal Investigator of the trial said, “The trial is progressing as expected with respect to patient safety and efficacy. We are encouraged by the favorable outcome of this interim analysis as one more step forward toward improving the management of knee osteoarthritis symptoms, especially for the most severe (KL4) patients, who are not adequately addressed with current non-surgical treatment modalities.” The fully enrolled 516 patient Phase 3 trial is a prospective, double-blind, multicenter, placebo-controlled, parallel group, randomized control trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the treatment of subjects with moderate to severe symptomatic knee osteoarthritis (OA). Patients were ra...