Organogenesis Holdings Inc. announced that its second Phase 3 randomized controlled trial (RCT) of ReNu for symptomatic knee osteoarthritis (OA) did not achieve statistical significance for its primary endpoint. The primary endpoint was the reduction in knee pain at six months, assessed by the WOMAC pain scale.
Despite not reaching statistical significance, the ReNu results demonstrated a numerical improvement in baseline pain reduction over the first Phase 3 trial, with a reduction of -6.9 compared to -6.0. The study also continued to show a favorable safety profile for ReNu.
Organogenesis plans to request a pre-Biologics License Application (BLA) meeting with the FDA by the end of October to discuss the submission pathway. The company intends to use a combined efficacy analysis from both Phase 3 studies to support a BLA approval, maintaining confidence in ReNu's potential as an innovative pain management therapy for knee OA.
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