With all due respect...
Anything over 15% reduction is deemed clinically significant, and worthy of further investigation. Thus, we head to Phase 3 in FSGS, with US FDA ORPHAN DISEASE RECOGNITION.
Sparsentan dropped the proteinuria by 26.3% over gold standard. And they took gold standard as being 18.5% reduction.
DXB has typically used the 2001 definition of irbesartan gold standard as being significantly higher at 24%.
DMX-200 dropped proteinuria by a further 29% on average over the study participants OVER gold standard.
It works BETTER than Sparsentan.
Even without using an abnormally low irbesartan response.
If DXB used Retrophin’s definition, then the results are even better.
Ann: Positive Top-Line Results in FSGS Phase 2a Clinical Study, page-27
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