DXB Media thread., page-290

I have shared it before and will do again for new investors.

In May 2023, US drug developer Travere announced that its candidate sparsentan had failed its Phase 3 primary endpoint (eGFR)

However, this also means that DMX-200 now has the potential to be the first drug approved for FSGS.

DMX-200 has a very different mechanism of action to sparsentan – whereas Travere were trying to build a better ARB/endothelin receptor antagonist, we are targeting an entirely new inflammatory pathway for patients already receiving standard of care (CCR2 antagonist).

The design of our study is also entirely different. Travere ran what is called a comparator (active) arm study, as opposed to a placebo-controlled study. Whilst sparsentan itself appeared to perform reasonably well, they saw a large and unexpected response their comparator (active) control arm and this looks to have negatively impacted the statistical significance of their study.

In contrast, Dimerix’ study is placebo controlled and Dimerix have been very careful to design the study without a change to background therapy to minimise placebo effects on the control arm.

From the start, we have always targeted total eGFR slope (which means kidney function) as our primary endpoint, as we are fortunate that our drug does not have an initial acute effect on eGFR that can make statistical testing difficult, as it may have done with sparsentan.

The above is the summary of my discissions over last few months with Nina who is very approachable and respond to inventor queries unlike a lot of other Biotech CEO's.

I will reach out to her again for the Q3'25 analysis as there are certain things I want to clarify and will update the group accordingly.

Thanks