Organogenesis Holdings Inc. (NASDAQ: ORGO) shared topline data on Thursday from the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA).
ReNu is a cryopreserved, amniotic suspension allograft (ASA) developed for managing symptomatic knee osteoarthritis.
ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components.
ReNu received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Knee OA in 2021.
Data
The trial did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial.
Baseline pain reduction at six months for ReNu was -6.9 for the second Phase 3 study compared to -6.0 in the first Phase 3 study.
Additionally, the ReNu results continued to demonstrate a favorable safety profile.
The primary endpoint for the study is the difference between the ReNu and Saline groups in the reduction in knee pain at six months, assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale.
The study demonstrated a numerical improvement of -0.51 favoring ReNu (p=0.0393 one-sided p-value, compared to p=0.023 target threshold). The first Phase 3 trial achieved improvement of -0.72, favoring ReNu, which was statistically significant (p=0.0177, one-sided p-value, compared to p=0.023 target threshold).
“As a next step, we will request a pre-BLA meeting with the FDA by the end of October to discuss the submission pathway, including using the combined efficacy analysis from both Phase 3 studies to support a BLA approval,” said Patrick Bilbo, Chief Operating Officer of Organogenesis said in a press release on Thursday.
ReNu has now been studied in three large RCTs of more than 1,300 patients combined.
ORGO Price Action: Organogenesis Holdings shares were down 15.49% at $3.95 at the time of publication on Friday. The stock is trading within its 52-week range of $2.61 to $6.71, according to Benzinga Pro data.
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