Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that its pivotal Phase 3 clinical trial evaluating rexlemestrocel-L for the treatment of chronic low back pain (CLBP) associated with degenerative disc disease has achieved its patient recruitment target. This marks a significant milestone in Mesoblast’s plans for commercialization of rexlemestrocel-L, its proprietary allogeneic stromal cell therapy targeting inflammatory processes underlying disc degeneration.

The placebo-controlled study (MSB-DR004) will follow at least 300 patients randomized to a single intra-discal injection of rexlemestrocel-L or sham control for 12 months. The trial seeks to confirm results from the earlier MSB-DR003 trial where a single intra-discal injection of rexlemestrocel-L resulted in clinically meaningful reductions in pain and opioid usage for up to three years.

The trial’s primary endpoint is powered to show a significant difference in reduction of low back pain 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 after the last randomized patient has completed follow-up. A positive readout will be used in support of an expected regulatory filing in Q3 CY2027 for United States Food and Drug Administration (FDA) approval. Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of CLBP due to degenerative disc disease providing eligibility for priority review once the Biologics License Application (BLA) has been filed.

Silviu Itescu, Chief Executive of Mesoblast, said: “This is 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.”

CLBP caused by inflammation and degenerative disc disease is a serious condition with a prevalence of over 7 million people in the U.S. alone. The indication is a potential blockbuster for Mesoblast with potential peak year revenue of >US$10 billion with single digit market penetration.