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Mesoblast (ASX:MSB) has completed patient treatment in its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain, marking a major milestone as the company moves towards a potentially important clinical readout in 2027.
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The MSB-DR004 trial has now randomised and treated 350 patients, with participants receiving either an intradiscal injection of rexlemestrocel-L or a sham injection.
The trial is designed to test whether a single injection of rexlemestrocel-L can deliver durable pain reduction at 12 months in patients with chronic low back pain associated with inflammatory degenerative disc disease.
The 12-month pain reduction is the primary endpoint, while secondary measures include improvements in physical function and quality of life, as well as reductions in pain medication use, including opioids.
Mesoblast said the 350 patient cohort provides the trial with the statistical power needed to assess whether patients receiving rexlemestrocel-L achieve a greater treatment benefit than those receiving the sham procedure.
Topline results are expected in mid-2027, once the final treated patient has completed 12 months of follow-up.
The trial represents an important next test for rexlemestrocel-L after the treatment previously met the 12-month primary endpoint in Mesoblast’s earlier Phase 3 MSB-DR003 trial.
Mesoblast CEO Silviu Itescu described completion of treatment as a major milestone, with the company now focused on the eventual 12-month data readout.
The commercial opportunity is potentially significant if the therapy demonstrates efficacy and subsequently receives approval. Mesoblast estimates chronic low back pain associated with degenerative disc disease affects more than 7 million people in the US, with the company estimating potential peak annual revenue of more than US$10 billion even with single-digit market penetration.
For investors, the immediate focus now shifts from enrolment and treatment to the quality of the Phase 3 data. The mid-2027 readout will be the key catalyst for determining whether rexlemestrocel-L can progress towards regulatory submission and potentially become a major commercial product for Mesoblast.
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