Clinical TrialJul 13, 2026, 08:36 PM
Mesoblast completes patient enrollment for Phase 3 CLBP trial
AI Summary
Mesoblast Limited announced the completion of patient enrollment, reaching its target of at least 300 patients, in the pivotal Phase 3 randomized controlled trial (MSB-DR004) for rexlemestrocel-L. This trial aims to confirm durable pain reduction for chronic low back pain (CLBP) associated with degenerative disc disease. The company expects top-line results in mid-CY2027, with commercial manufacturing proceeding in parallel for a swift approval filing. Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy (RMAT) designation, and the indication represents a potential blockbuster market exceeding US$10 billion in peak annual revenue.
Key Highlights
- Mesoblast completed enrollment of at least 300 patients in its pivotal Phase 3 trial (MSB-DR004) for rexlemestrocel-L.
- The trial targets chronic low back pain (CLBP) associated with degenerative disc disease.
- Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
- The indication has a potential peak year revenue of >US$10 billion with single-digit market penetration.
- Top-line results from the trial are expected in mid-CY2027.
- The primary endpoint is a significant reduction in low back pain at 12 months.
- CLBP caused by degenerative disc disease affects over 7 million people in the U.S.
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