Ann: Positive Top-Line Results in DKD Phase 2 Clinical Study, page-596

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vrs37

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26/09/20

09:43

Post #: 47645780
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Originally posted by SteadyEddie: ↑

Thanks for the detailed analysis OvF. As a medico I thought I'd jump in and clarify some things for others.
Facts so far -
In FSGS: Orphan Drug status for DMX- 200 in FSGS was gained in December 2015. The recent FSGS trial results announced 29 July showed that DMX-200 drug works is patients with deteriorating kidney function reducing the rate of albuminuria ( protein loss in the urine) by average 29%. The mechanism of action is thought to be reducing damaging levels of inflammation. The average starting level of proteinuria in this group was 411mg/mmol - remember this number.... If you can reduce proteinuria you can delay / prevent the need to go on dialysis at cost $100,000 per year. Having orphan drug status means potentially you can charge up to about $80,000 per year per patient for DMX-200. Multiply that by the 80,000 patients with FSGS in USA and you get big numbers. The recent diabetic trial doesn't change any of these numbers.
Looking at Diabetic kidney disease (DKD): inclusion criteria same as earlier trials proteinuria >30mg/mmol, overall result not significantly better than placebo. BUT - still positive result in those with more serious disease > 57mg/mmol (18% improvement). In previous studies only patients with much higher levels of proteinuria actually joined the trials but in this study there were a significant proportion with only mild disease. Thus it seems that it works in more serious disease only. This is consistent with the FSGS trial - remember the average 411mg/mmol entry level for patients - much higher than the DKD trial. This is useful information to proceed to the phase 3 trial - patients with mild disease will be excluded. The market is still huge for severe disease. Looking forward to reading the in depth analysis by researchers.

My conclusion - DMX-200 appears to be an effective anti-inflam agent in mod - severe kidney disease - but we still need confirmation with a larger phase 3 trial.

Covid: study yet to start for DMX-700 - similar mechanism of action to reduce excessive inflammation without side effects associated with steroids.

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Good summary
this is one I’m watching
Pfizer did stop development of their Ccr2i due to insufficient benefit in kidney disease but this DXB product might be better.
agree best go for moderate/ high albuminuria group.
not sure why they did the cut at 500 unless that was prespecified otherwise looks arbitrary.
test will be whether in phase 3 it protects not just kidney but also reduces cardiac endpoints, maybe even additive to AZ’s farxiga?

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