An order of treatment effect was noted in both FSGS and diabetic kidney disease studies, where the treatment group receiving DMX-200 first did not return to baseline during the wash-out period, resulting in a significantly lower starting baseline proteinuria in the second period (slides 12 and 19 in the attached presentation). A potential disease modifying effect has not been ruled out, where the patient may have continued DMX-200 benefit through the washout period, after they had stopped taking DMX-200. This can be an indicator that the drug may be having a lasting positive effect on the function of the kidney. No concomitant medications effect trends were noted in either study. “I believe that the results of this Phase 2a FSGS study further validates Dimerix’ lead candidate, DMX-200, in sclerotic kidney diseases. The positive signals suggest that treatment with DMX-200 may indeed result in clinically meaningful improvements in kidney function when added to the standard of care in patients with FSGS,” commented Dr Hiddo Heerspink, Chair of the Dimerix Medical Advisory Board. “I am very excited at what this may mean for future studies in patients with FSGS.” Dr Nina Webster, CEO and Managing Director of Dimerix, also commented “The positive correlation of reduced inflammatory biomarkers with a reduction in proteinuria following treatment with DMX-200 further strengthens our understanding of how DMX-200 is delivering clinically meaningful outcomes for these kidney patients. The significant body of clinical evidence Dimerix has established with DMX-200 supports progressing into a larger, randomised, controlled pivotal clinical trial in FSGS, with a pathway to accelerated approval.” Further analysis of the remaining data and planning of next steps for diabetic kidney disease are underway with the Medical Advisory Board.
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