Mesoblast Limited (MESO) has completed patient recruitment for its pivotal Phase 3 trial of rexlemestrocel-L in chronic low back pain, marking a major step toward advancing a potential non-opioid therapy for a condition affecting millions.
Chronic low back pain (CLBP) linked to degenerative disc disease is one of the most common causes of disability in adults, often leading to long-term discomfort, reduced mobility, and heavy reliance on pain medications, including opioids.
The Phase 3 study, MSB-DR004, has now enrolled at least 300 patients who will receive either a single intra-discal injection of rexlemestrocel-L or a sham control. Participants will be followed for 12 months. The primary endpoint measures reduction in low back pain at the one-year mark, while secondary endpoints assess improvements in function, quality of life, and reductions in pain medication use.
This confirmatory trial builds on earlier Phase 3 results, where a single injection of rexlemestrocel-L led to meaningful reductions in pain and opioid use for up to three years. The therapy, an allogeneic stromal cell product designed to target inflammation in degenerating discs, holds RMAT designation from the U.S. FDA, allowing for priority review once a Biologics License Application is filed.
Top-line data from the current study are expected in mid-2027, with a potential regulatory submission planned for the third quarter of that year if results are positive.
Mesoblast's CEO Silviu Itescu, said the milestone supports the company's goal of delivering a disease-modifying, non-opioid option for patients with chronic low back pain- an area of significant unmet need.
Chronic low back pain affects more than 7 million people in the U.S. and accounts for nearly half of prescription opioid use, underscoring the demand for safer, long-term treatment alternatives.
MESO has traded between $9.88 and $21.50 over the past year. The stock closed Wednesday's trading at $15.22, down 0.72%. During overnight trading, the stock rose to $16.00, up 5.12%.
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