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Highlights

  • Second Phase 3 trial shows numerical improvement in pain reduction over the first trial.
  • The study did not meet the primary endpoint but maintained statistically significant function.
  • Company plans pre-BLA meeting with FDA to discuss submission pathway.

Organogenesis Holdings Inc. (Nasdaq:ORGO) announced an update on its second Phase 3 randomized controlled trial (RCT) of ReNu®, a cryopreserved amniotic suspension allograft (ASA) for symptomatic knee osteoarthritis (OA). While the study did not achieve statistical significance for its primary endpoint, the results showed a numerical improvement in baseline pain reduction compared with the first Phase 3 trial.

Baseline pain reduction at six months for ReNu was -6.9 in the second trial, compared to -6.0 in the first. The primary endpoint measured the difference between ReNu and saline groups in knee pain reduction at six months, assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale. The second Phase 3 study showed a numerical improvement of -0.51 favoring ReNu (p=0.0393 one-sided), slightly below the target threshold of p=0.023. The first Phase 3 trial achieved -0.72 favoring ReNu with statistical significance (p=0.0177 one-sided, compared to p=0.023 target threshold).

Function and Safety
 The study reported a statistically significant maintenance of function (p<0.0001) and confirmed a favorable safety profile for ReNu. The trial enrolled 594 patients across multiple centers in a prospective, double-blind, saline-controlled, parallel-group design. Participants received a single intra-articular injection of either ReNu or saline.

ReNu has now been studied in three large RCTs encompassing over 1,300 patients. The FDA granted ReNu Regenerative Medicine Advanced Therapy (RMAT) designation based on its potential to address an unmet medical need related to a serious condition.

Company Overview
 Organogenesis Holdings Inc. is a regenerative medicine company focused on developing, manufacturing, and commercializing solutions for advanced wound care and surgical and sports medicine markets.