DXB Chart, page-216

From everything I have read so far, I am expecting Clarity (1) to show ARB has no statistical effect on outcomes (which will likely be seen as a negative for us, however it is unrelated). Clarity 2 and REMAP-CAP will more likely provide an improvement in recovery and has additional value potential in the secondary endpoints - recovery and quality of life post hospitalization (long covid assessment) and larger application in CAP - community acquired pneumonia, not just covid.

Likelyhood of success in COVID trials would have no bearing on FSGS trials.

2nd Analysis Accelerated Approval Endpoind: n=144 (72 1st Analysis + 72), Proteinuria + eGFR at week 35

July 21 release:

Accelerated approval on interim data

The FDA was broadly supportive of the proposed Phase 3 study design. The meeting minutes from the FDA provided clarity on the single Phase 3 study in FSGS patients to support accelerated approval endpoints, such as protein in the urine (proteinuria) and its relationship to kidney function (eGFRslope). The FDA confirmed that improvement in proteinuria was an acceptable surrogate endpoint for accelerated approval, with sufficient demonstration of the relationship to kidney function. The FDA also provided guidance on the statistical analysis of the data used to support the accelerated approval.

July 20 Phase 2a results:




22 december 2021:

If effective in the treatment of COVID-19, DMX-200 may be equally effective across all strains
and other infection-related pneumonias

DMX-200 prevents recruitment of activated monocytes to areas of inflammation by blocking signalling of CCR2. This mechanism of action relates to the host (human) immune response to all infections, rather than a specific virus or strain leading to the conclusion that if DMX-200 is successful in showing benefit for patients with one strain of COVID-19, it would likely be effective against the different COVID-19 strain mutations based on its mechanism of action.... Therefore, if CCR2 inhibition is effective for patients with COVID-19, the common mechanism of action would likely be effective against any strain as well as potentially other pneumonias with a common mechanism of action