MESO Reaches Patient Recruitment Target in Phase 3 CLBP Trial
Mesoblast Limited announced it has achieved its patient recruitment target for the pivotal Phase 3 clinical trial evaluating rexlemestrocel-L for chronic low back pain (CLBP) associated with degenerative disc disease. This placebo-controlled study will follow at least 300 patients for 12 months, with top-line results anticipated in mid-CY2027. A positive readout will support an expected regulatory filing in Q3 CY2027 for FDA approval, leveraging the drug's Regenerative Medicine Advanced Therapy (RMAT) designation. The company views this as a major milestone towards commercializing a non-opioid therapy for a condition affecting over 7 million people in the U.S., with a potential market exceeding $10 billion in peak year revenue.
Key Highlights
- Pivotal Phase 3 trial for rexlemestrocel-L in chronic low back pain (CLBP) achieved patient recruitment target.
- The placebo-controlled study (MSB-DR004) will follow at least 300 patients for 12 months.
- Primary endpoint is significant reduction in low back pain at 12 months.
- Top-line results are expected in mid-CY2027.
- Regulatory filing for FDA approval is expected in Q3 CY2027.
- Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
- CLBP affects over 7 million people in the U.S. alone.
- Potential peak year revenue for the indication is >$10 billion with single-digit market penetration.