DXB 3.13% 31.0¢ dimerix limited

"As the earlier trials have shown nothing close to 30%...

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    "As the earlier trials have shown nothing close to 30% proteinuria reduction with the DMX drug, I'm not sure why they think they will achieve that here but we'll find out at some point if the drug performs better than expected."

    Don't necessarily agree with this comment. If you look back at the three Phase 2 trials completed to date - the dose escalating study showed that 54% (n=13) achieved at least a 30% reduction in PCR at any does level. The DKD trial was measured against albuminuria creatine ratio (ACR rather than PCR as per other trials), so might be a bit more difficult to interrogate. And the FSGS trial had 2 of 7 patients with a response >= 40% on DMX-200 (on top of the benefit from placebo / Irbesartan); and 1 of 7 with a response of >= 50% on both DMX-200 and placebo (most likely having taken DMX first before crossover to the placebo indicating a possible lasting effect).

    And also bearing in mind that in relation to the endpoint for eGFR slope - every trial completed to date has monitored eGFR in patients from baseline right through to the end of the trial. This data hasn't been reported but they definitely have it in their possession. I'm not sure that they have access to monitoring eGFR in patients that continued to use DMX-200 after the trials were completed to get a better idea of long term benefits. But they would at least have a good grip on whether they were seeing any promising indications of eGFR slope improvement in relation to PCR reduction during the trials and surely this is what has dictated the thresholds for study powering and endpoints? They wouldn't have intentionally set themselves up for failure. And increasing the number of patients (even if it meant taking longer to recruit and complete the trial) would have been the obvious path to achieve a lower eGFR improvement endpoint with sufficient power if they thought they were being way too ambitious with the 1.68 ml/min/1.73m2 target?!

    We'll have plenty of time to think about that before the next milestone though. First things first is we just need to see a good result from this first milestone.
    Last edited by butcherano: 27/02/24
 
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