Ann: Dimerix Confirms Phase 3 FSGS Study Design With EMA, page-29

Retrophin also had some safety issues with an increase in peripheral oedema (an issue that affects FSGS sufferers anyway) & hypotension with Spartensan. They were stated as keeping a close eye on these issues in Ph3 that were identified in Ph2. It isn’t just about the reduction in proteinuria, the patients have to have QOL as well & a reduction in troublesome symptoms/side effects.

So it maybe that the FDA wants more data, it’s a new drug candidate, unlike DMX-200 that is repurposed (used to treat hepatitis in Japan for many years but heavily patented by Dimerix in renal indications plus patents in for COVID-19/ARDS) + Ibersartan (ARB) that has been on the market >20 years (gold standard for FSGS) & a plethora of data behind that.

We have not seen significant safety issues with DMX -200, but of course every clinical trial is going to report AEs whether they are drug related or not, & in a disease like FSGS there will be many due to the course of serious & terminal disease that cannot be treated with renal transplant in the most part, as the new kidney succumbs as well (ie hyperkalaemia, nausea & vomiting) & then the inherent risks of dialysis & immunosuppression on current treatment.

We also know that DMX-200 can potentially work synergistically as an adjunct therapy with Sparsentan & improve reduction in proteinuria on top of what is achieved (see recent ANN). So if the data is good, this may replace Ibersartan as gold standard in FSGS, inspite of ironing out some side effects. I don’t think that Sparetensan is really deemed to be a “competitor” to DMX-200, but potentially replacing Ibersartan as gold standard for treatment, yes (off patent, cheap, available in generic form).

So some differences there already in the background with DMX-200 + ARB vs Sparsentan in Ph3.

GLTAH