Cynata Therapeutics Limited (ASX: $CYP) has announced the completion of participant recruitment in the Phase 3 SCUIpTOR clinical trial of CYP-004, a Cymerusâ„¢ off-the-shelf iPSC-derived MSC product candidate for intra-articular injection. The trial, conducted by the University of Sydney (USYD), has surpassed the revised target sample size with a total of 321 participants enrolled. Patients will be followed up for two years, with the last participant visit expected around November 2025 and results anticipated in the first half of 2026.
We are delighted that recruitment in this trial has been completed. There is a pressing need for safe and effective disease-modifying treatments for osteoarthritis, a debilitating condition affecting a large global adult population with no cure. As such, this trial was designed to evaluate the ability of Cymerus MSCs to affect the two most important outcomes in osteoarthritis: reduction in pain and disease modification. We look forward to receiving the results, which could have substantial influence on clinical practice in the future.
Cynata Therapeutics (ASX: $CYP) has successfully completed participant recruitment in the Phase 3 SCUIpTOR clinical trial of CYP-004, a Cymerusâ„¢ off-the-shelf iPSC-derived MSC product candidate for intra-articular injection. The trial, conducted by the University of Sydney (USYD), surpassed the revised target sample size with 321 participants enrolled. The company anticipates the last participant visit to occur around November 2025, with results expected in the first half of 2026. Dr Jolanta Airey, Cynata's Chief Medical Officer, highlighted the need for safe and effective disease-modifying treatments for osteoarthritis and expressed anticipation for the trial results. Dr Kilian Kelly, Cynata's CEO and MD, emphasized the significance of this milestone and the potential impact on clinical practice. Cynata's Cymerus technology has shown promise in various indications, and the company remains optimistic about the trial's outcomes and their influence on future medical practices.