Clinical TrialJul 14, 2026, 08:01 AM
Mesoblast achieves 300-patient target in Phase 3 CLBP trial
AI Summary
Mesoblast Limited announced it has achieved its target of at least 300 patients treated in the pivotal Phase 3 randomized controlled trial of rexlemestrocel-L for chronic low back pain (CLBP). The trial aims to confirm durable pain reduction from a single intra-discal injection. Top-line results are anticipated in mid-CY2027, and rexlemestrocel-L holds Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
Key Highlights
- Mesoblast achieved its target of 300 patients treated in the pivotal Phase 3 trial.
- The trial is for rexlemestrocel-L for chronic low back pain (CLBP).
- Primary endpoint is significant pain reduction at 12 months.
- Top-line results are expected in mid-CY2027.
- Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation.
- Potential peak year revenue for the indication is over $10 billion.
- CLBP affects over 7 million people in the U.S.
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