Mesoblast (ASX:MSB) says it has completed enrolment in a phase 3 clinical trial evaluating a single intra-discal injection of its allogeneic mesenchymal precursor cell (MPC) product candidate MPC-06-ID in patients with chronic low back pain due to degenerative disc disease.
MPC-06-ID is being evaluated to determine whether it can alleviate pain and improve function in patients who do not receive adequate relief from the current standard of care therapies such as nonsteroidal anti-inflammatory drugs, epidural steroid injections or opioids.
The 2:1 randomised, placebo-controlled phase 3 trial (NCT02412735) enrolled 404 patients across 48 centres in the US and Australia.
The company said the trial's primary endpoint is in line with written guidance from the US FDA in support of product registration. It specifies: use of a composite measurement showing significant clinical improvement in pain and function at both 12 and 24 months; pre-specified thresholds for determining significant improvement in pain (50 percent decrease in Visual Analog Score) and function (15-point improvement in Oswestry Disability Index); and, patients who undergo additional interventions at the treated level are considered treatment failures.
According to the company, phase 2 results in 100 patients showed that a single intra-discal injection of MPC-06-ID alleviated pain and improved function for up to three years in patients whose symptoms were not adequately treated with current standard of care therapies.
“There is an urgent need to provide an effective treatment for patients suffering from chronic low back pain due to degenerative disc disease, a population which today accounts for 50% of prescription opioid usage. If the Phase 3 results demonstrate durable improvement in pain and function, MPC-06-ID has the potential to make a major difference in patients with this serious medical condition,” said Mesoblast CEO Dr Silviu Itescu.