Clinical TrialApr 28, 2026, 08:55 PM
MESO Phase 3 CLBP trial hits recruitment target; results mid-CY27
AI Summary
Mesoblast announced its pivotal Phase 3 clinical trial for rexlemestrocel-L in chronic low back pain (CLBP) has met its patient recruitment target. The placebo-controlled study (MSB-DR004) involves 300 patients and aims to confirm previous positive results. Top-line results are expected in mid-CY2027, with a regulatory filing for FDA approval anticipated in Q3 CY2027. Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation, qualifying it for priority review.
Key Highlights
- Pivotal Phase 3 CLBP trial (MSB-DR004) achieved patient recruitment target.
- Study involves at least 300 patients randomized to rexlemestrocel-L or sham control.
- Primary endpoint: significant reduction in low back pain at 12 months.
- Top-line results expected in mid-CY2027.
- Regulatory filing for FDA approval anticipated in Q3 CY2027.
- Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation.
- CLBP affects over 7 million people in the U.S.
- Potential peak year revenue for the indication is >$10 billion.
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