DMX-200 Available To Patients Via Post-Trial Access Pathways
2026-07-09 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗
Dimerix is a biopharmaceutical company developing innovative new therapies in areas with unmet medical needs. Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. [email protected] For Immediate Release DMX-200 TO BE MADE AVAILABLE TO PATIENTS THROUGH POST-TRIAL ACCESS PATHWAYS Key Highlights: • Post-trial access to be introduced, enabling continued treatment with DMX -200 for eligible patients • Patients who have completed participation in the ACTION3 Phase 3 trial and Open Label Extension Study may continue to receive DMX-200, in consultation with their physician • Supports ongoing treatment for patients with FSGS who may benefit from DMX-200 • Dimerix’ commercial partners to be responsible for applicable post -trial access arrangements in their respective territories, with Dimerix responsible for those territories currently unlicensed • Reflects Dimerix’, and its commercial partners , commitment to patient continuity of care and unmet medical need • Enables access to investigational therapy prior to regulatory approval, subject to regulatory oversight MELBOURNE, Australia, 9 July 2026: Dimerix Limited (ASX: DXB) (“Dimerix” or the “Company”), a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, is pleased to announce that DMX-200 will be made available to eligible patients through post -trial access pathways in key territories following participation in the ACTION3 Phase 3 Clinical Trial and Open Label Extension (OLE) study. Post-Trial Access for Continuing Patients The post-trial access program is intended to support continued access to DMX-200 for eligible patients with focal segmental glomerular sclerosis (FSGS) who have completed treatment in the Company’s ongoing clinical trial and, in consultation with their treating physician, wish to remain on therapy. Post-trial access generally refers to continued access for eligible participants after completion of a clinical trial or open -label extension, where ongoing treatment is considered appropriate by the treating physician and where they have no access to a suitable alternative therapy. Depending on the jurisdiction, post-trial access may be provided through expanded access, compassionate use, special access or equivalent regulatory pathways. These pathways allow access to investigational therapies outside a clinical trial, before regulatory approval, in circumstances permitted by local requirements. Access through these pathways does not constitute regulatory approval and therapies remain investigational during this period. Data collection for patients receiving DMX-200 under the Post Trial Access program is limited primarily to safety data. “We are committed to ensuring that patients with FSGS, who have participated in our clinical program, have the opportunity to continue treatment with DMX-200 where appropriate. The post- trial access pathways reflect both the unmet medical need in this patient population and the encouraging patient experience observed to date with DMX-200.” Dr David Fuller, Chief Medical Officer, Dimerix Access for eligible patients will be subject to applicable local regulatory frameworks and depending on the jurisdiction, may be implemented through expanded access, compassionate use, special access or equivalent pathways, as appropriate. The Company’s commercial partners will be responsible for applicable access arrangements in their respective territories, including covering the cost of supply of DMX-200, with Dimerix responsible for those territories where a commercialisation partner has not been appointed. About FSGS Phase 3 Study The ACTION3 Phase 3 study is a pivotal Phase 3, 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 a blood pressure medication known as an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients are then randomised to receive either DMX-200 (120 mg capsule, twice daily) or placebo for a 2 -year treatment period. The single Phase 3 trial in FSGS patients is designed to capture evidence of proteinuria reduction and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval, with percent change in proteinuria being the primary endpoint. Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or the Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier : ACTRN12622000066785). For further information, please visit our website at www.dimerix.com or contact: Dr Nina Webster Dimerix Limited Chief Executive Officer & Managing Director Tel: +61 1300 813 321 E: [email protected] Jane Lowe IR Department Tel: +61 411 117 774 E: [email protected] Follow Dimerix on LinkedIn and X Authorised for lodgement by the Board of Dimerix —END— About Dimerix Limited Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including kidney diseases. Dimerix is currently focused on developing its proprietary Phase 3 product candidate DMX-200, for Focal Segmental Glomerulosclerosis (FSGS) kidney disease. DMX -200 was 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. For more information, please visit the company’s website at www.dimerix.com and follow on X and LinkedIn. About DMX-200 DMX-200 is 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 va rious territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to Orphan Drug Designation granted in the United States, Europe, UK and Japan 1 . DMX-200 is an investigational medicine and has not been approved for marketing by any regulatory authority at this time. Access under the post-trial access pathways does not imply regulatory approval or confirm clinical efficacy. About FSGS FSGS is a rare, serious kidney disorder characterised by progressive scarring (sclerosis) in parts of the glomeruli—the kidney’s filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In the United States, more than 40,000 people are estimated to be living with FSGS, including both adults and children. 2 There are no therapies specifically approved for FSGS in the U.S., and disease management relies on non -specific immunosuppressive and supportive therapies. In patients with progressive or treatment -resistant FSGS, the average time from diagnosis to end -stage kidney disease can be as short as five years. Even among those who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases, 3 underscoring the urgent need for new, disease-modifying treatments. Dimerix Forward Looking Statement This release includes forward -looking statements that are subject to risks and uncertainties. Although management believes that the expectations reflected in the forward-looking statements are reasonable at this time, Dimerix can give no assurance that these expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward -looking statements. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, results of clinical trials, contractual risks, risks associated with patent protection, future capital needs or other general risks or factors, including but not limited to those factors outlined in the most recent Dimerix Limited Annual Report. References 1 ASX releases: 14 December 2015, 21 November 2018, 07 June 2021, 30 September 2025 2 Nephcure FSGS Facts (https://nephcure.org/) 3 Front. Immunol., (July 2019) | https://doi.org/10.3389/fimmu.2019.01669
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