FDA's Office Agrees On 12-Month Reduction In Pain As Primary Endpoint For Mesoblast's Back Pain Study

Mesoblast Limited MESO received feedback from the FDA's Office of Tissues and Advanced Therapies (OTAT) on the Phase 3 program of rexlemestrocel-L in patients.

• The trial is assessing rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative disc disease refractory to available therapies, including opioids.
• Mesoblast plans to conduct an additional U.S. Phase 3 trial which may support submissions for potential approval in the U.S. and EU. 
• The trial will include at least 20% of subjects from the EU to support global submission plans. 
• Following the data review, OTAT agreed with Mesoblast's proposal for pain reduction at 12 months as the primary endpoint of the subsequent trial.
• Functional improvement and reduction in opioid use will be secondary endpoints.
• Suppose this trial is successful and leads to EU regulatory approval. In that case, Mesoblast is eligible to receive up to $112.5 million before the product launch in the EU from its partner in Europe and Latin America, Grünenthal. 
• Cumulative milestone payments could reach US$1 billion depending on the outcome of Phase 3 studies.
• Related Link: Why Mesoblast Shares Are Falling
• Price Action: MESO shares are up 5.63% at $5.25 during the premarket session on the last check Thursday.