Mesoblast Hits 300-Patient Milestone in Phase 3 Low Back Pain Trial
Mesoblast has enrolled 300 patients in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, randomizing subjects to a single intradiscal injection or sham control. Top-line results are expected mid-2027 to underpin an FDA BLA filing in Q3 2027, targeting over $10 billion peak sales.
1. Trial Recruitment Milestone
Mesoblast has completed enrollment of 300 patients in its MSB-DR004 confirmatory Phase 3 trial evaluating a single intradiscal injection of rexlemestrocel-L versus sham control for chronic low back pain due to degenerative disc disease across multiple U.S. sites.
2. Study Design and Endpoints
The randomized, placebo-controlled study will follow patients for 12 months with a primary endpoint of low back pain reduction; key secondary measures include improvements in function, quality of life and cessation of pain medications including opioids.
3. Timeline and Regulatory Path
Top-line data are anticipated by mid-2027 to support a planned FDA Biologics License Application submission in Q3 2027. Rexlemestrocel-L holds RMAT designation, enabling rolling review and priority FDA evaluation.
4. Market Opportunity
Chronic low back pain affects over 7 million Americans and accounts for approximately 50% of opioid prescriptions. Rexlemestrocel-L is projected to target a peak annual market exceeding $10 billion with single-digit market penetration.