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DIMERIX LIMITED

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Dimerix Limited Announces Phase 3 Study in FSGS Kidney Patients Commences

08/24/2021 | 06:43pm EST

Dimerix Limited announced that it has now commenced ACTION3, the Phase 3 clinical study in patients with focal segmental glomerulosclerosis (FSGS), with the first ethics submission having been filed in Australia, enabling commencement of patient recruitment once approved. Up to 167 sites in up to 18 countries across North America, South America, Europe, United Kingdom, and Asia Pacific regions are expected to participate in this study, with Australia and New Zealand identified as the first countries planned to initiate patient recruitment across 5 sites collectively and other countries following shortly after. ACTION Phase 3 Study Design: The Phase 3 study, which is titled "Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis" ­ or ACTION3 for short, is a pivotal (final), multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients, aged 18 to 75 years, will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo. The primary endpoint for potential accelerated marketing approval is the percent change in protein in the urine (proteinuria) from Baseline to Week 35 following treatment with DMX-200 compared with placebo; and the primary endpoint for full approval is the slope of eGFR from Baseline to Week 104 following treatment with DMX-200 compared with placebo. A blinded interim analysis will be performed in approximately 70 patients following Part 1 of the study to confirm both efficacy and study powering (for statistical measures), which based on the estimated patient recruitment rate, is anticipated as early as the December quarter of 2022. The decision to continue the study will be made by an independent data monitoring committee based on the results of this interim analysis. If the study is recommended to proceed, the remaining 180 patients will be enrolled into Part 2 of the study.


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Financials
Sales 2021 4,44 M 3,16 M 3,16 M
Net income 2021 -6,37 M -4,54 M -4,54 M
Net cash 2021 0,16 M 0,11 M 0,11 M
P/E ratio 2021 -6,06x
Yield 2021 -
Capitalization 72,2 M 51,4 M 51,4 M
EV / Sales 2020 26,7x
EV / Sales 2021 8,66x
Nbr of Employees -
Free-Float 91,5%
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Managers and Directors
Nina Webster Chief Executive Officer, MD & Director
Hamish George Chief Financial Officer & Secretary
James Howard Williams Non-Executive Chairman
David Packham Chief Medical Officer
Robert Shepherd Director-Research & Development
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