In a Feb. 11 research report, Dawson James Securities analyst Jason Kolbert reported that the results of Mesoblast Ltd.'s (MESO:NASDAQ; MSB:ASX) Phase 3 trial of MPC-06-ID, or rexlemestrocel-L, for treatment of degenerative disc disease-caused chronic lower back pain "look good" and "approval could follow."
"The data shows that a that injection of rexlemestrocel-L appears to provide durable and effective opioid sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease. Relief appears to be durable for two years-plus from a single administration," the analyst wrote.
Kolbert reviewed the new study data.
In this Phase 3 trial, more than 400 patients with chronic lower back pain (CLBP) were administered one injection containing six mesenchymal precursor cells and hyaluronic acid. The majority of patients, 391 of them, experienced "significant and durable reductions in CLBP," and pain relief continued through the 24-month follow-up period.
A subset of patients, 194 of them, experienced greater pain relief than the others. At the start of the trial, this group had fewer than 68 months of constant pain, the median pain duration of the entire study population. Further, this subset experienced that heightened pain relief at each point it was assessed, at 1, 3, 6, 12, 18 and 24 months.
A different subset of patients, this one of opioid users (n=169), also experienced greater pain relief at each of those same time points.
For the patients who went into the study already having CLBP for more than 68 months, "the composite outcomes of pain and function did not reach statistical significance across the entire study," noted Kolbert.
Study participants did not report any adverse events throughout the 24-month follow-up period.
Kolbert also pointed out that a previous randomized controlled trial of combination MPC-06-ID and hyaluronic acid, the Phase 2 trial, showed durable pain reduction.
Given all of these results, Mesoblast intends to meet with the U.S. Food and Drug Administration to discuss next steps and a pathway to approval of MPC-06-ID plus hyaluronic acid as a treatment for CLBP due to degenerative disc disease.
Dawson James has a Buy rating and a $16 per share price target on Mesoblast, the current share price of which is about $10.30.[NLINSERT]
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