Interpretation of phase 2B clinical trial results

Hi all,

Curious to see how everyone else is interpreting this chart from the phase 2b results. I think it's the best estimator of phase 3 results as it was double-blinded, whereas SAS is not a clinical trial.



It appears the mean reduction of pain at Day 53 based on the 9 KOOS questions was about 14.5 for iPPS and 8 for placebo.

Questions I'm not sure of:

1. Are the numbers in the chart based on KOOS raw score?
2. Is KOOS raw score out of 36? ie. 9 questions based on a 0-4 rating subscale
3. What was the mean baseline of the n=112 patients out of 36? (That line they drew at the 10 mark suggests that mean baseline was 20, as a reduction of 10 would represent 50% reduction?)
4. Is the mean of the 5 WOMAC questions likely to deviate from the mean of the 9 KOOS questions? It would've been nice if they just extracted the 5 WOMAC questions for us and shown the score out of 20 instead.

Anyway, I made a spreadsheet to try and account for the different possible baselines and calculate the 'margin of safety' (ie. whether we are scraping a pass in the exam or acing it). I've assumed a 30% pain reduction as the pass mark for 'clinically meaningful'. Not sure why placebo is >30%?? Though placebo was 33% reduction in the tanezumab trial from memory.