Mesoblast Limited (ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today announced the completion of patient treatment in its pivotal randomised controlled Phase 3 trial, MSB-DR004. The company, which develops allogeneic (off-the-shelf) cellular medicines for severe and life-threatening inflammatory conditions, is evaluating rexlemestrocel-L for chronic low back pain (CLBP) associated with the inflammatory condition of degenerative disc disease. This significant milestone saw 350 patients randomised and treated with either an intra-discal injection of rexlemestrocel-L or a sham injection, an increase from the initial 300 patients due to strong investigator demand.
The trial’s primary endpoint aims to confirm durable pain reduction at 12 months from a single intra-discal injection of rexlemestrocel-L, consistent with findings from the earlier MSB-DR003 trial. Secondary endpoints include improvements in function, quality of life, and the cessation of pain medication, including opioids. Mesoblast Chief Executive Silviu Itescu remarked, “Completing treatment of 350 patients in our pivotal low back pain trial is a momentous milestone for the company as we now count down to the 12-month read-out for what we hope will be the basis of our first blockbuster product.”
Chronic low back pain caused by inflammation and degenerative disc disease is a serious condition affecting over 7 million people in the U.S. alone, representing a potential peak year revenue of more than US$10 billion for Mesoblast with just single-digit market penetration. Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), providing eligibility for priority review once the Biologics License Application (BLA) is filed. Top-line results from the trial are expected in mid-CY2027, following the completion of 12-month follow-up for the last treated patient.
