DIMERIX LIMITED Dimerix retains all rights to commercialise DMX-200 outside of these territories. DMX-200 is currently in global Phase 3 clinical development.
Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients, and ADVANZ will be responsible for submission and maintenance of the regulatory dossier in the licensed territories, as well as all sales and marketing activities. In exchange for these rights, Dimerix will receive an upfront payment of
Dimerix and ADVANZ will form a
Dimerix continues to pursue and progress licensing opportunities with potential partners outside the ADVANZ territories.
CEO & Managing Director of Dimerix, Dr
Professor
About
About ACTION3 FSGS Phase 3 Study
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 (Phase 3), multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomized to receive either DMX200 (120 mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.
About Dimerix
Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including both kidney and respiratory diseases. Dimerix is currently focussed on developing its proprietary Phase 3 product candidate DMX-200 (QYTOVRA in some territories), for Focal Segmental Glomerulosclerosis (FSGS) kidney disease, and is also developing DMX-700 for Chronic Obstructive Pulmonary Disease (COPD). DMX-700 and DMX-700 were both identified using Dimerix' proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities.
About DMX-200
DMX-200 is the adjunct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker - the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to any exclusivity period that may apply in key territories. In 2020, Dimerix completed two Phase 2 studies: one in FSGS and one in diabetic kidney disease, following a successful Phase 2a trial in patients with a range of chronic kidney diseases in 2017. No significant adverse safety events were reported in any trial, and all studies resulted in encouraging data that could provide meaningful clinical outcomes for patients with kidney disease.
About FSGS
FSGS is a rare disease that attacks the kidney's filtering units, where blood is cleaned (called the 'glomeruli'), causing irreversible scarring. This leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation. For those diagnosed with FSGS the prognosis is not good. The average time from a diagnosis of FSGS to the onset of complete kidney failure is only five years and it affects both adults and children as young as two years old.[i] For those who are fortunate enough to receive a kidney transplant, approximately 60% will get re-occurring FSGS in the transplanted kidney.[ii] At this time, there are no drugs specifically approved for FSGS anywhere in the world, so the treatment options and prognosis are limited.
FSGS is a billion-dollar plus market: the number of people with FSGS in the US alone is just over 80,000,2 and worldwide about 220,000.[iii] The illness has a global compound annual growth rate of 8%, with over 5,400 new cases diagnosed in the US alone each year.[iv] Because there is no effective treatment, Dimerix has received Orphan Drug Designation for DMX 200 in both the US and
Contact:
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Email: enquiries@advanzpharma.com
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