Mesoblast has completed patient treatment in the MSB-DR004 pivotal randomized, placebo-controlled Phase 3 trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease, with 350 patients randomized and treated.
The treated population increased from 300 to 350 after investigator demand, according to the company. The trial’s primary endpoint is durable pain reduction at 12 months from a single intra-discal injection, aiming to confirm results seen in the earlier MSB-DR003 trial, and secondary endpoints include improvements in function, quality of life and cessation of pain medications including opioids.
Rexlemestrocel-L has Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration and top-line results are expected in mid-calendar year 2027 after the last treated patient completes 12 months of follow-up.
The company claims the indication could yield peak U.S. revenue of more than US$10 billion with single-digit market penetration. Mesoblast also notes Ryoncil is an FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease.
