CYP completes Phase 3 trial for CYP-004; results expected 2026

Cynata Therapeutics Limited (ASX: CYP) announces the completion of participant enrollment in the Phase 3 SCUlpTOR clinical trial for CYP-004, its Cymerus™ off-the-shelf iPSC-derived MSC product for intra-articular injection. The University of Sydney conducted the randomized, placebo-controlled trial, surpassing the revised sample size target with 321 participants. As per the study protocol, patients will be followed for two years to assess potential disease-modifying effects, with the last participant visit expected around November 2025.

Results, expected in H1 2026, from the CYP-004 Phase 3 trial funded by an Australian NHMRC grant will focus on co-primary endpoints. Endpoints: participants achieving acceptable knee pain state, femorotibial cartilage change (MRI) at 24 months in CYP-004 trial. The trial signifies a significant step in evaluating the efficacy of Cynata Therapeutics' Cymerus™ product.

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