Mesoblast Limited (ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today announced a significant achievement in its pivotal Phase 3 clinical trial. The biotechnology company, which develops off-the-shelf cellular medicines from proprietary mesenchymal lineage cell therapy technology platforms that counter severe inflammation, has successfully met the patient recruitment target for its study evaluating rexlemestrocel-L. This investigational therapy targets chronic low back pain (CLBP) associated with degenerative disc disease, marking a crucial step towards its potential commercialisation.
The placebo-controlled study, MSB-DR004, is designed to follow at least 300 randomised patients receiving a single intra-discal injection of rexlemestrocel-L or a sham control over a 12-month period. The trial’s primary objective is to demonstrate a significant reduction in low back pain at 12 months between the active treatment and control groups. This aims to confirm earlier positive results from the MSB-DR003 study, where a single injection of rexlemestrocel-L showed clinically meaningful reductions in pain and opioid usage for up to three years. Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids.
Mesoblast anticipates top-line results from the study in mid-calendar year 2027, after all randomised patients complete follow-up. A successful outcome is expected to support a regulatory filing with the United States Food and Drug Administration (FDA) in the third quarter of calendar year 2027 for potential approval. Rexlemestrocel-L has previously been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, providing eligibility for priority review once the Biologics License Application is submitted. Mesoblast Chief Executive, Silviu Itescu, highlighted this as a “major milestone toward delivering on our corporate goal of bringing to market a non-opioid, disease-modifying therapy for patients suffering from chronic low back pain, a condition with significant unmet medical need.”
