Reply to @MongooseMan (HC reply function not working again).My...

Reply to @MongooseMan (HC reply function not working again).

My point is that we need to be targeting the right patient population for the Phase 3 trial that will have a higher chance of showing a significant improvement on DMX-200.

And your stats for ACR are way off according to feedback from Dimerix. 30 mg/mmol (300mg/g) isn’t a high threshold. The internationally recognised threshold for patients with the worst prognosis is 57 mg/mmol (500mg/g) - listen from around the 11min mark here. Our Phase 3 trial design has eligibility criteria of 169 mg/mmol PCR which would be equivalent to approx 85 mg/mmol ACR. Which shows that we’re targeting a patient population that is most likely to benefit from DMX-200.

Making reference to a recommendation to start taking SGLT2 inhibitors at ACR levels of 200 mg/g is misleading with respect to clinical trial designs. It makes sense to recommend this for use of an approved drug if it will stabilise or improve the patient from that level in the real world. But if you’re undertaking a clinical trial for a new drug then you’re going to find it difficult to show statistically significant results for patients that are towards the healthy end of the spectrum. They might stabilise and not worsen on the drug during the trial. But that wouldn’t necessarily mean that it was the drug that caused the benefit and it wasn’t just the fact that they haven’t deteriorated of their own doing. What you want to see from the trial is that you’ve clearly showed improvement for patients that have a worse baseline condition and you’re certain that this has resulted from taking the drug. And I think our trial has been designed with this in mind.