The Mesoblast Limited (ASX: MSB) share price is up 5% after making a trial announcement.
Mesoblast describes itself as a global leader in allogeneic cellular medicines for inflammatory diseases.
What happened with Mesoblast’s trial?
Mesoblast announced the results from the phase 3 randomized controlled trial of its all allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments.
The results indicate that a single injection of rexlemestrocel-L may provide a “safe, durable and effective opioid-sparing therapy” for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process, and that the greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred.
Mesoblast explained that regulatory approval of pharmaceutical agents, such as opioids, in the treatment of chronic pain syndromes generally requires reduction in pain as the primary outcome. In the midst of the opioid epidemic in the US, the Food and Drug Administration has prioritised a focus on new therapeutics that target both pain reduction and opioid avoidance, particularly for treating CLBP which accounts for 50% of opioid prescriptions.
In addition to assessing the durability of pain reduction with rexlemestrocel-L treatment, this study evaluated primary outcomes using composite measures of pain reduction together with functional responses to treatment, as well as exploratory composites of pain reduction and functional responses in the context of opioid reduction.
Management comments
Mesoblast CEO Dr Silviu Itescu said: “The durable pain reduction for at least two years from a single administration indicates that rexlemestrocel-L has the potential to change the treatment paradigm for chronic low back pain due to inflammatory disc disease, a condition that affects as many as seven million patients across the United States and Europe, and to prevent or reduce opioid use and dependence.”
Summary thoughts
Mesoblast continues to be very volatile. The Mesoblast share price has been steadily rising throughout February, though there is a long way to go to reach its former heights where it was at the end of 2020.
It’s an interesting business, but it’s not the type of investment I’d want to make where the outcome is either good or bad. It’s also hard to know how good or bad the news is as someone without a healthcare background.
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