• FDA agreed proteinuria could be primary endpoint for full marketing approval of DMX-200 in the US
• Suitable proteinuria endpoints include proportion of patients achieving defined reduction or percent change from baseline
• Existing eGFR slope change to be pre-specified as secondary endpoint

Dimerix, a biopharmaceutical company, announced that the FDA has confirmed proteinuria as an appropriate primary endpoint for full marketing approval of DMX-200 in the US for Focal Segmental Glomerular Sclerosis (FSGS). The FDA agreed that suitable proteinuria endpoints could include either a statistically significant increase in the proportion of patients achieving a defined proteinuria reduction compared to placebo after 2 years, or a statistically significant reduction in proteinuria from baseline (percent change) compared to placebo after 2 years. The FDA also proposed that the existing eGFR slope change endpoint should be pre-specified as a secondary endpoint. This outcome is a significant and positive result for DMX-200, given Dimerix' prior pre-clinical and clinical analysis has already demonstrated encouraging effects on change in proteinuria levels. Dimerix is now working with the PARASOL working group to generate additional analysis to further assess what may represent an appropriate and meaningful endpoint for accelerated approval, which will be discussed with the FDA. Dimerix will also undertake a blinded statistical powering analysis of the ACTION3 Phase 3 clinical trial once the additional PARASOL work is complete and the primary and secondary endpoints have been pre-specified.

Dimerix is working with the PARASOL working group to generate additional analysis to further assess what may represent an appropriate and meaningful endpoint for accelerated approval, which will be discussed with the FDA.