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Positive results from Mesoblast Limited’s (NASDAQ: MESO) chronic back pain treatment trial have boosted investor confidence sending the company’s shares higher in the premarket after an announcement showing its stem cell treatment for chronic lower back pain is “safe, durable, and effective.”
Phase 3 trial results have shown that a single injection of rexlemestrocel-L in 404 enrolled patients suffering from lower back pain due to degenerative disc disease results in at least two years of pain reduction. Significantly greater pain reduction was reported in the patient subset of opioid users too.
Further, Mesoblast says the most significant benefits are seen when the mesenchymal precursor cell therapy is administered earlier in the disease process before the disc’s irreversible degeneration has occurred.
Mesoblast will meet with the FDA to discuss the results of the trial.
In December last year, Mesoblast announced topline data from the rexlemestrocel-L Phase 3 trial in patients with advanced chronic heart failure. Over a mean 30 months of follow-up, rexlemestrocel-L treated patients on top of maximal therapies had a 60% reduction in the incidence of heart attacks or strokes and a 60% reduction in death from cardiac causes. Despite the significant decrease in the pre-specified endpoint of cardiac death, there was no reduction in recurrent non-fatal decompensated heart failure events, which was the trial’s primary endpoint.
The company also suffered another setback after a monitoring committee noted that the rexlemestrocel-L is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrollment for respiratory distress syndrome due to COVID-19 infection. However, no safety concerns were observed.
Price Action: MESO stock gained 22.4% at $12.13 in premarket trading on the last check Thursday.
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