Banter and general comments, page-32

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vrs37

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12/08/24

12:55

Post #: 75168430
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Originally posted by cdoyle: ↑

you truly are clueless, you can't say that it was only 17% in phase 2 its not how the trial was constructed. It was 17% on top of ARB standard of care. So, overall "29% of patients demonstrated >40% reduction in proteinuria". There has not been a comparison with DMX without an ARB so you can't compare 17% of DMX on top of an ARB to 38% from Fabhalta. DMX is to be prescribed to patients on an ARB, so the effect in combination is what is measured. Hence, was for almost 1/3 of patients in the P2 study, greater than 40%.

Its the same as a chemotherapeutic being prescribed in combination with another drug. You can't measure the effect of one of the drugs distinctly, it is the combination that is providing the benefit so needs to be considered together.

You even say it in your first sentence "got to be cautious about comparing" then you go ahead and exactly that and make yourself look ill informed.

Also, the approval from Fabhalta yesterday where the primary endpoint was protein urea reduction bodes well for Dimerix receiving an accelerated approval on that interim endpoint alone.

FSGS tends to progress towards kidney failure more rapidly than IgAN, C3G and IC-MPGN - particularly with high protein urea.

Even with both the Novartis drug and Apellis drugs being on the path to approval, there is still the market for DMX-200.

DMX is targeting FSGS, and is looking for accelerated approval on protein-urea. Both of the other two drugs mentioned above are looking to be approved on this end-point.

DMX is an adjunct therapy with the standard of care, and can work in combination with spartsenan or just the ARB. This provides other benefits like patients don't need to stop taking their blood pressure medication if they need to take an FSGS drug. Approximately 80% of Chronic Kidney disease patients suffer from hypertension as well, so taking DMX-200 will not jeopardise the therapeutic effects of concurrently taking irbesartan. Whereas spartsenan may do this.

I think overall the above really just demonstrates a strengthening position of DMX within this market.

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I'm clueless you say?
>>>Firstly it is "proteinuria" ie protein in the urine, not "protein urea" - which is meaningless, so I'd suggest you get the term right first.
>>>second, yes I can say it is 'only' 17% vs placebo. I understand the study design. The fabhalta result is also vs placebo and also on top of RAS blockade (ARB/ACE inhibitor), both arms active and control had to be on optimal RAS blockade, so for fabhalta it is also 38% ON TOP OF standard of care. Suggest you look at their trial design.
you'd be better off checking your own knowledge before commenting, else you just expose your own ignorance as you've done here...

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Banter and general comments, page-32

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