Ann: Dimerix Confirms Phase 3 FSGS Study Design With EMA, page-28

Hi Butter & All,

@NZ Trader, no idea about the volume, but what I do know is that we are progressing nicely in the Regulatory department towards Ph3 in orphan disease FSGS.

As far as the cost of the trial (Ph3) goes, it was ~A$30 million the figure discussed. As others have said here, rare disease requires much smaller & a single Ph3 as opposed to the traditional pathway to approval & commercialisation. Retrophin are actually running dual Ph3 trials (FSGS & IgA Nephropathy), so I’m not sure if that is where the $75 million number comes from @HS2912?

The other thing is that I did ask Nina directly some time ago whether we would be including paediatric patients on the FSGS trial (as Retrophin have done) & she said that each population must represent the “intent to treat” in the clinical trial, so we may well be seeing older kids included on the trial also, as FSGS also affects children.

@ButterRobot yes AstraZeneca very big on drug development for kidney disease. Their SGLT2 drug (diabetes)Farxiga/Forxiga has been hitting goals with regulatory approval for CKD/CVD & they are also in collaboration with RenalytixAI (diagnostics) to develop further drug candidates in kidney disease as you have put up in your post (thank you).

I don’t think anyone Is forgetting DKD either (there is no fundamental reason that DMX-200 cannot be used as an adjunct treatment (on top of ARB/SGLT2) & to me that is interesting, because the SGLT2 market is extremely competitive & the drugs all have similar numbers & indications. Pairing of an adjunct therapy in combination treatment could give a greater advantage in reduction of Albuminuria over competitors (we have discussed this at length before in relation to DKD).

@NZ Trader, I’m guessing the next lot of news will be confirmation of patient enrolment & dosing on CLARITY 2.0 in India (COVID-19). Then maybe an update on REMAP-CAP? @singhgu getting excited haha, good to see (great post).

Have a great day folks