I just thought I would rehash the phase 2 trial results and the relevance to the phase 3 trial.
The phase 2 trial post-hoc analysis of the composite endpoint developed with the FDA of "at least a 50% improvement in low back pain, 15 point improvement in ODI and no treatment intervention (surgical or injection)" found:
44.4% of the 6m MPC group met the endpoint at 6 and 12 months (p=<0.05)
37% of the MPC 6m group met the endpoint at 12 and 24 months (p=0.09)
Compared with 11.8% of the saline/placebo group at both 6-12 and 12-24 months
The phase 3 trial uses the 6m MPC dose as this was found to be most effective in the phase 2 trial and importantly the primary endpoint is this exact composite endpoint developed with the FDA over a timeframe of 24 months.
This means that if the 6m MPC group has any % higher than the placebo group even if it isn't as strong as the results above it will successfully meet the primary endpoint.
Ideally, we would want the phase 2 results repeated or even stronger results.
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