Ann: Positive Top-Line Results in DKD Phase 2 Clinical Study, page-307

I’ve mulled over the phase IIb data more now and have some concerns popping up that all should be aware of

Main comment: individual patient data needs to be shown for the low albuminuria subgroup. I suspect it’s left out because according to my calculations, this group would have over 20% increase in albuminuria (clinically significant increase)... 26 high albuminuria patients have an average reduction of 18%, but then when you add in the low albuminuria patients then you get an overall average of 2% reduction. Therefore, there must be a high increase in albuminuria in these less sick patients considering there are only 14 of them. This won’t be a good look for pharma, even if dxb plans to move forward in only sicker patients. There will be questions around how to ensure the drug does not cause increased albuminuria in certain patients.

this cannot be explained by legacy effect since you would expect to see the legacy effect most prominently in the responders (high albuminuria), yet they still had a placebo corrected reduction in albuminuria. While the low albuminuria patients had a placebo corrected increase in albuminuria.

this also raises my concerns about the FSGS phase ii data as they did not show individual patient data for that but reported that two patients had quite a high reduction in proteinuria. This would mean the other 4 patients had minimally reduced proteinuria. Then we also have the issue of how they handled correcting for placebo in each individual patient in that study, which to my knowledge has not been explained yet.

just want everyone to be aware of the subanalysis risks here. Hopefully a remap cap trial announcement comes before hand to inject some positivity into this stock first.

I’m going to watch from the sidelines from now because I can’t afford more pain from this stock now that red flags are appearing.

i really do hope they have a good explanation for this.