DIMERIX INVESTOR CALL & PRESENTATION
FSGS phase 3 study design
A randomised, double-blind, multi-centre, placebo-controlled study of renal outcomes
of DMX-200 in patients with primary FSGS receiving an ARB
ACTION3
FSGS CLINICAL STUDY
Dimerix
ARB stabilisation
weeks -6
-1 0
Recruited
Treatment period
35
All patients will remain on ARB treatment at a stable and maximal tolerated dose
Randomisation
•
Stabilise ARB and any
other medications (as
appropriate)
• 1st dose
DMX-200
Placebo
T
I
1st interim analysis; n=72, proteinuria at week 35
⚫2nd analysis Accelerated Approval endpoint;
n=144* (72 1st analysis + 72), proteinuria + eGFR at
week 35
104
• Final analysis (n=286)
eGFR slope at week 104
ARB: Angiotensin Receptor Blocker
*Subject to recruitment rate and conditional power
10
Accelerated endpoint: Marketing approval for serious conditions that fill an unmet medical need based on a surrogate or an intermediate clinical endpointView entire presentation