The company said top-line results for rexlemestrocel-L in chronic low back pain are expected in mid-CY2027, with the study designed to support a potential FDA filing and priority review eligibility.
Mesoblast said its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease has reached its target of at least 300 treated patients, a milestone the company says leaves the placebo-controlled study adequately powered for its primary endpoint. The trial is testing whether a single intra-discal injection can deliver durable pain reduction at 12 months versus sham controls, with secondary measures covering function, quality of life and cessation of pain medication, including opioids. Mesoblast said commercial manufacturing is advancing in parallel so it can move quickly toward a Biologics License Application (BLA) if the data support approval. Rexlemestrocel-L has RMAT (FDA expedited program for regenerative medicines) designation from the FDA (U.S. Food and Drug Administration), which the company said provides eligibility for priority review once a BLA is filed. Top-line results are expected in mid-CY2027 after the last treated patient completes 12 months of follow-up.