In a significant step towards innovative pain management solutions, Mesoblast Limited (Nasdaq:MESO; ASX:MSB) has received encouraging feedback from the U.S. Food and Drug Administration (FDA) regarding its allogeneic cell therapy, rexlemestrocel-L. This therapy is being evaluated for patients suffering from chronic discogenic low back pain (CLBP). The FDA’s insights come after a thorough review of data from Mesoblast’s initial randomized controlled Phase 3 trial, known as MSB-DR003, which explored pain reduction and its implications for opioid use over a span of three years.
Mesoblast is actively pursuing FDA approval for rexlemestrocel-L, focusing on its ability to significantly reduce chronic low back pain over a twelve-month period. The results from the MSB-DR003 trial demonstrated that patients receiving rexlemestrocel-L experienced a notably greater reduction in pain intensity compared to those on placebo, a finding acknowledged by the FDA. The agency confirmed that the substantial pain relief observed in the active treatment group supports the efficacy of the product and can be highlighted in its labeling.
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Continued Research and Development
In addition to the positive feedback from the FDA, Mesoblast is conducting a second Phase 3 trial, MSB-DR004, which is currently enrolling participants across 40 locations in the United States. This trial is halfway to its goal of enrolling 300 patients, with expectations to complete the recruitment process within the next three months. This research is particularly relevant considering the ongoing opioid crisis in the U.S., where chronic low back pain is a leading contributor to opioid prescriptions.
Regulatory Designation and Implications
Rexlemestrocel-L has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, which signifies its potential as a significant treatment option for CLBP. This designation grants Mesoblast various benefits, including opportunities for enhanced review processes and priority status during the Biologics License Application (BLA) submission. The implications of this designation are profound, particularly in the context of current opioid-related health crises.
According to Mesoblast’s CEO, Silviu Itescu, the introduction of rexlemestrocel-L could offer a robust alternative for managing chronic inflammatory back pain, potentially aiding in the reduction or cessation of opioid use among patients.
Insights into Chronic Low Back Pain
Chronic low back pain, primarily caused by inflammatory conditions and degenerative disc disease (DDD), affects millions in the U.S. alone, representing a critical public health issue. It is estimated that this condition impacts over 7 million individuals, making it a primary source of disability and a key factor in the high rates of opioid prescriptions. In fact, nearly half of all prescription opioids dispensed in the U.S. are attributed to managing CLBP.
Furthermore, the ramifications of CLBP extend beyond physical discomfort. Patients often experience a diminished quality of life, impaired ability to perform daily tasks, and adverse effects on mental health. The connection between chronic pain and opioid dependency highlights the urgent need for effective, non-opioid therapeutic options.
Impact of Mesoblast’s Clinical Trials
In Mesoblast’s initial Phase 3 trial, out of 404 participants, 168 were using opioids at the start. Remarkably, those treated with a single injection of rexlemestrocel-L combined with hyaluronic acid were over three times more likely to completely stop using opioids within three years compared to the control group (p=0.008). This significant finding underscores the therapy’s potential to not only alleviate pain but also to reduce reliance on addictive medications.
About Mesoblast and Its Commitment
Mesoblast is a pioneer in the development of allogeneic cell therapies, focusing on treatments for severe inflammatory conditions. Their proprietary technology leverages the body’s own repair mechanisms, utilizing mesenchymal lineage cells to combat inflammation effectively. The company’s flagship product, Ryoncil®, is the first FDA-approved therapy of its kind for treating steroid-refractory acute graft versus host disease in pediatric patients.
With ongoing research and a strong intellectual property portfolio, Mesoblast is dedicated to advancing therapies like rexlemestrocel-L for various indications, including heart failure and chronic low back pain. The company operates in multiple regions, including Australia, the U.S., and Singapore, and is actively expanding its global footprint.
