Pivotal Phase 3 Trial in CLBP Achieves 300 Treated Patients

• Achieved target of 300 patients in pivotal Phase 3 trial for CLBP
• Aims to confirm durable pain reduction from earlier trial
• Rexlemestrocel-L has FDA Regenerative Medicine Advanced Therapy designation

Mesoblast Limited has announced the completion of its target of treating at least 300 patients in the MSB-DR004 pivotal Phase 3 randomized controlled trial for chronic low back pain (CLBP) associated with degenerative disc disease. The trial aims to confirm the durable pain reduction from a single intra-discal injection of rexlemestrocel-L seen in the earlier MSB-DR003 trial. The trial's primary endpoint is to show a significant difference in pain reduction at 12 months between rexlemestrocel-L and sham controls. Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids. Top-line results are expected in mid-CY2027.