Organogenesis Holdings Inc. (ORGO) has announced positive interim results from its second Phase 3 clinical trial evaluating ReNu, a cryopreserved amniotic suspension allograft (ASA), for the treatment of knee osteoarthritis (OA). The independent Data Monitoring Committee (DMC) recommended that the trial proceed without modification, signaling confidence in the treatment's efficacy and safety profile.
The interim analysis included 50% of the planned 474 patients with moderate to severe knee OA, focusing on the 6-month primary endpoint. The trial is a prospective, double-blind, multicenter, saline-controlled, parallel group, randomized control trial (RCT).
Trial Design and Endpoints
The Phase 3 trial enrolled 594 patients who were randomized to receive a single intra-articular (IA) injection of either ReNu or a saline control. The primary endpoint is the reduction in knee pain, assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale. This scale is a widely used tool for evaluating pain, stiffness, and physical function in patients with osteoarthritis.
Patrick Bilbo, Chief Operating Officer of Organogenesis, stated, "We have passed another critical milestone in the ReNu development program. We are pleased with the outcome of the interim analysis which indicates the study is in the favorable zone and consistent with the assumptions for the statistical plan and efficacy expectations."
Addressing a Significant Unmet Need
Knee OA is a degenerative joint disease affecting approximately 31.1 million Americans, with projections estimating a rise to 34.4 million by 2027. It is a leading cause of disability and reduced quality of life, characterized by pain and functional limitations. Current treatment options range from conservative measures like physical therapy and pain medication to total knee replacement as a last resort.
Adam B. Yanke, MD, PhD, Associate Professor of Orthopedics and Vice Chair of Research at Rush University Medical Center, and Co-Principal Investigator of the trial, commented, "Based on our progress to date, we are encouraged that the results of this study, when complete, will further strengthen the clinical evidence supporting ReNu as a safe and effective non-surgical treatment option for patients suffering from knee OA pain."
Implications for Regenerative Medicine
The positive interim analysis suggests that ReNu could offer a valuable non-surgical option for managing knee OA symptoms. The DMC's recommendation to proceed without modification underscores the potential of ReNu to meet a significant unmet need in the treatment of this prevalent and debilitating condition. Further results from the trial are eagerly anticipated to confirm these promising findings.
