- Mesoblast (MSB) receives the green light for a new trial on chronic low back pain due to degenerative disc disease
- The news follows feedback from the US FDA on the phase three program investigating the use of rexlemestrocel-L in patients with the lower back pain
- The company says it plans to conduct an additional US phase three trial which may support submissions for potential approval in both the US and Europe
- If this trial is successful, Mesoblast says it will be eligible to receive payments up to US$112.5 million (A$156.9 million) prior to product launch from its partners in Europe and Latin America
- Mesoblast is up 11.28 per cent to $1.48 per share as of 11:14 am AEDT
Mesoblast (MSB) has received the green light for a new trial on chronic low back pain due to degenerative disc disease.
The news follows feedback from the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) regarding the phase three program investigating the use of rexlemestrocel-L in patients with the lower back pain.
Rexlemestrocel-L is Mesoblast’s product in development for advanced chronic heart failure and chronic low back pain
The company said it plans to conduct an additional US phase three trial which may support submissions for potential approval in both the US and Europe.
If this trial is successful and leads to European regulatory approval, Mesoblast said it will be eligible to receive payments up to US$112.5 million (around A$156.9 million) prior to product launch from its partner in Europe and Latin America, Grünenthal. This will be inclusive of US$17.5 million (roughly A$24.4) already received.
Following review of the completed trial data, OTAT agreed with Mesoblast’s proposal for pain reduction at 12 months as the primary endpoint of the next trial, with functional improvement and reduction in opioid use as secondary endpoints.
Mesoblast is up 11.28 per cent to $1.48 per share as of 11:14 am AEDT.