• Mesoblast completed patient treatment in Phase 3 trial for CLBP
• 350 patients randomized and treated in the trial
• Trial aims to confirm durable pain reduction at 12 months
• Secondary endpoints include improvements in function and quality of life
• Top-line results expected in mid-CY2027

Mesoblast Limited, a global leader in allogeneic cellular medicines for inflammatory diseases, has completed patient treatment in its MSB-DR004 pivotal randomized controlled Phase 3 trial for chronic low back pain (CLBP) associated with degenerative disc disease. The trial, which randomized and treated 350 patients, aims to confirm the durable pain reduction at 12 months from a single intra-discal injection of rexlemestrocel-L, previously seen in the MSB-DR003 trial. Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids. The trial's primary endpoint aims to confirm the durable pain reduction at 12 months from a single intra-discal injection of rexlemestrocel-L seen in the earlier MSB-DR003 trial. With 350 treated patients, the trial is well-powered for showing a greater treatment benefit in patients receiving rexlemestrocel-L compared with controls. Top-line results are expected in mid-CY2027 after the last treated patient has completed 12 months follow-up.

Top-line results expected in mid-CY2027

The company anticipates that the trial results will form the basis for their first blockbuster product, potentially generating significant revenue.