Patient Enrollment Begins in Phase 3 Rexlemestrocel-L Trial for Chronic Low Back Pain

On July 21, 2024, Mesoblast Limited, a leader in the development of allogeneic cellular medicines for inflammatory diseases, announced the initiation of a pivotal Phase 3 clinical trial for its stromal cell product, rexlemestrocel-L. This product is aimed at treating chronic low back pain (CLBP) due to inflammatory degenerative disc disease lasting less than five years. Enrollment for this trial has started at various locations across the United States.

The U.S. Food and Drug Administration (FDA) has previously agreed on the design of this 300-patient, randomized, placebo-controlled trial. The primary goal is to achieve pain reduction over a 12-month period, which the FDA considers an approvable indication. Secondary goals include improvements in quality of life, functionality, and a reduction in opioid use.

The FDA has granted rexlemestrocel-L the designation of Regenerative Medicine Advanced Therapy (RMAT) for treating chronic low back pain. This designation offers benefits similar to Breakthrough and Fast Track designations, including rolling reviews and eligibility for priority review when a Biologics License Application (BLA) is submitted.

Dr. Alan Miller, MD, a trial investigator at Coastal Health Specialty Care in Jacksonville, Florida, stated, "This therapy has the potential to be groundbreaking and life-changing for the low back pain population."

Dr. Eric Rose, Mesoblast's Chief Medical Officer, expressed enthusiasm about the ongoing trial. “We are very excited to be actively enrolling our pivotal trial of rexlemestrocel-L across multiple sites and look forward to confirming the durable pain reduction previously observed in the first Phase 3 trial. There is a significant need for a safe, effective, and durable treatment in patients with CLBP and degenerative disc disease, in particular one that reduces or eliminates opioid use.”

Chronic low back pain is a leading cause of disability among Americans under 45 years old, with an annual prevalence of 10-30% in the general U.S. adult population. Inflammation and degenerative disc disease account for CLBP in over seven million Americans. This condition significantly impacts patients' quality of life, limiting daily activities, reducing work capacity, and affecting mental health. CLBP also accounts for roughly half of prescription opioid use in the U.S., contributing to the opioid crisis.

Mesoblast leverages its mesenchymal lineage cell therapy technology to develop a portfolio of late-stage product candidates targeting severe inflammation. The company's proprietary technology releases anti-inflammatory factors that modulate various immune system components, effectively reducing the damaging inflammatory process.

Mesoblast boasts a robust global intellectual property portfolio, extending at least until 2041 in major markets. The company’s manufacturing processes enable the production of industrial-scale, cryopreserved, off-the-shelf cellular medicines, making these therapies readily available to patients worldwide.

The company is developing products for different indications based on its remestemcel-L and rexlemestrocel-L stromal cell technology platforms. Remestemcel-L is being explored for pediatric and adult inflammatory diseases, including steroid-refractory acute graft versus host disease and biologic-resistant inflammatory bowel disease. On the other hand, rexlemestrocel-L is being targeted for advanced chronic heart failure and chronic low back pain. Mesoblast's licensees have commercialized two products in Japan and Europe, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets.

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