Organogenesis Reports Positive Interim Results for Phase 3 ReNu Knee Osteoarthritis Trial

On November 11, 2024, Organogenesis Holdings Inc. (Nasdaq: ORGO), a major player in regenerative medicine, revealed a positive interim analysis from its second Phase 3 clinical trial of ReNu. This cryopreserved amniotic suspension allograft (ASA) is being studied for its efficacy in managing knee osteoarthritis (OA) symptoms.

The interim analysis covered 50% of the anticipated 474 patients with moderate to severe knee OA, classified under Kellgren-Lawrence (KL) grades 2 to 4. This analysis concentrated on the 6-month primary endpoint to potentially re-estimate the sample size. The independent Data Monitoring Committee (DMC), which maintained strict study blinding, offered directional guidance and recommended the trial continue unchanged. The DMC also confirmed that the safety data aligned with ReNu's known safety profile.

Patrick Bilbo, Chief Operating Officer of Organogenesis, stated, “We have passed another critical milestone in the ReNu development program. The interim analysis outcome is favorable and aligns with our statistical plan and efficacy expectations.”

The Phase 3 trial, fully enrolled with 594 patients, is a prospective, double-blind, multicenter, saline-controlled, parallel group, randomized control trial (RCT) of ReNu ASA for treating moderate to severe symptomatic knee OA. Patients were randomized to receive a single intra-articular (IA) injection of either saline control or ReNu. The primary endpoint is a reduction in knee pain, evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale.

Dr. Adam B. Yanke, Associate Professor of Orthopedics and Vice Chair of Research at Rush University Medical Center, and Co-Principal Investigator of the trial, expressed satisfaction with the trial's progress. He noted, “The progression of this second Phase 3 clinical trial is promising. We believe the final results will reinforce the clinical evidence supporting ReNu as a safe and effective non-surgical treatment for knee OA pain.”

Knee OA is a common degenerative joint disease affecting nearly 31.1 million Americans, with projections estimating an increase to 34.4 million by 2027. It often leads to significant pain and functional impairments, making it one of the leading causes of disability and reduced quality of life. Typically, end-stage management involves total knee replacement when other treatment options have been exhausted.

Organogenesis Holdings Inc. is dedicated to developing, manufacturing, and commercializing innovative regenerative medicine solutions for advanced wound care and the surgical and sports medicine markets. Their comprehensive portfolio addresses various patient needs across the continuum of care.