- Mesoblast (MSB) has spiked on the ASX this morning after revealing strong clinical trial results for treating chronic low back pain (CLBP)
- The company said a single dose of its rexlemestrocel-L treatment was able to significantly reduce back pain caused by degenerative disc disease for up to two years
- Importantly, the company said its treatment also helped reduce the use of opioids in trial patients
- This is significant given that, according to Mesoblast, CLBP accounts for half of all opioid prescriptions in the U.S.
- The trial tested three groups of patients: two received the rexlemestrocel-L treatment either with or without a hyaluronic acid carrier, while the third received a saline injection as a control
- Compared to the saline control, significant and durable reductions in CLBP over the whole 24 months was achieved across the entire study population
- Mesoblast said it now plans to speak with the FDA about getting the rexlemestrocel-L treatment approved in the States
- Shares in Mesoblast are up almost 5 per cent at midday and trading at $2.68 each
Mesoblast (MSB) has spiked on the ASX this morning after revealing strong clinical trial results for treating chronic low back pain (CLBP).
The company said a single dose of its allogeneic mesenchymal precursor cell (MPC) therapy, known as rexlemestrocel-L, can significantly reduce back pain caused by degenerative disc disease (DDD) for up to two years.
Mesoblast has been testing rexlemestrocel-L in over 400 trial patients predominantly in the United States. Importantly, on top of reducing pain with a single dose, the company's treatment has also helped reduce opioid use in trial patients with CLBP.
"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," Mesoblast's CEO, Dr Silviu Itescu, said.
This reduction in opioid use is particularly important given the U.S. Food and Drug Administration's (FDA) prioritised focus on new therapeutics that target pain reduction and opioid avoidance. According to Mesoblast, CLBP accounts for half of all opioid prescriptions in the States.
The rexlemestrocel-L trial
The trial saw 404 patients treated split into three groups. Two of the groups received a single injection of rexlemestrocel-L with a dose of six million MPCs, either with or without a naturally occurring substance known as hyaluronic acid (HA) as a carrier. The third group of patients received a saline control instead of the real drug.
The effect each injection had on CLBP was then monitored through various indexes and measurements, including a Visual Analog Score, the Oswestry Disability Index, and the EuroQoL 5-Dimensional Index.
And the results are clear.
Compared to the saline control, significant and durable reductions in CLBP over the whole 24 months was achieved across the entire study population. On top of this, there was significantly greater pain reduction in patients who were opioid users before the trial compared to the saline control.
In fact, even though patients were instructed to not change any medications during the trial, there was a 40 per cent reduction in opioid use in patients treated with the MPC and HA combination.
On the flip side, far more patients treated with the saline control actually increased their opioid use over the 24 months compared to other trial groups.
To top it off, there were no safety concerns over the 24-month period of follow up across the entire study population.
Mesoblast Chief Medical Officer Dr Fred Grossman said the results show "very meaningful improvements" in debilitating CLBP.
"On the basis of the phase three trial results, we intend to meet with the FDA and discuss potential pathways towards approval for rexlemestrocel-L, including as an opioid-sparing treatment in patients with DDD," he said.
Mesoblast shares are up 4.69 per cent at midday AEDT, trading at $2.68 per share. The company has a $1.57 billion market cap.
