drugset / Press release

FIRST PATIENT DOSED IN DMX-200 CLINICAL TRIAL

2018-11-19 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗

For Immediate Release DIMERIX DOSES FIRST PATIENT IN DMX-200 CLINICAL TRIAL FOR DIABETIC KIDNEY DISEASE • First patient dosed at Renal Research clinical study site in Gosford, New South Wales; • Study still enrolling across multiple Australian sites; • Preliminary results anticipated for Q4 of calendar year 2019. MELBOURNE, Australia, 19 November 2018: Dimerix Limited (ASX: DXB) today announced that the first patient has been dosed in the Company’s Phase 2 clinical study of DMX-200 for Diabetic Kidney Disease. This clinical study follows on from an initial study that investigated the effects of DMX -200 in patients broadly diagnose d with Chronic Kidney Disease, in which the subgroup of patients with Diabetic Kidney Disease showed a statistically and clinically compelling response. The patient was dosed at the Renal Research in Gosford, New South Wales clinical study site, overseen by Principal Investigator Simon Roger, and occurred in line with anticipated timelines. "We are delighted to have dosed the first patient in our Diabetic Kidney Disease trial . We hope that our DMX-200 treatment may be able to fill a significant treatment gap in the area of kidney disease,” said Dr Nina Webster, CEO of Dimerix. “The progressive nature of kidney disease inevitably results in poor outlook for patients, as it most often results in total kidney fail ure and a poor quality of life. A kidney transplant costs in the region of $260,000 per patient, with ongoing and expensive anti - rejection drugs also costing thousands of dollars per year. Dialysis costs are in the region of $100,000 per patient per year and consume about 12 hours per week in regular clinic visits. This is a huge burden on both the patient and the healthcare system. We believe DMX -200 has the potential to increase the life of the kidney by three to five years, which is significantly better for both the patient and the healthcare system." The study will enroll 40 eligible patients across Australia, who will receive two treatment blocks of 12 weeks (separated by a six week washout period) during which they will receive either placebo or DMX-200 (formulated as an easy-to-take capsule) in the first treatment block, then be switched to the alternative in the second treatment block. Every patient must receive 300 mg of Irbesartan daily for at least three months prior to screening, so that any reduction in p roteinuria, a recognised indicator, seen in the study can be solely attributed to the potential benefits of DMX-200. Dimerix is also enrolling patients for a separate, concurrent Phase 2 trial of DMX-200 for Focal Segmental Glomerulosclerosis (FSGS), an orphan disease. The two studies are both double-blind, randomised, placebo -controlled, crossover studies , evaluating the safety and efficacy of DMX -200 in patients who are receiving Irbesartan , the current standard of care . Clinical trial s ites were initiated, and patient recruitment commenced in September. Subject to patient recruitment rates, preliminary results are anticipated for both studies in Q4 of calendar year 2019. For further information, please visit our website at www.dimerix.com or contact the individuals outlined below. —END— At the Company Dr Nina Webster, Dimerix Limited Chief Executive Officer Tel: 1300 813 321 E:[email protected] Investor Relations Glen Zurcher, IR Department Account Director Tel: +61 420 249 299 E: [email protected] About Dimerix Bioscience Pty Ltd Dimerix Limited’s (ASX: DXB) wholly owned subsidiary Dimerix Bioscience Pty Ltd is a dynamic, clinical-stage drug development company, developing and commercialising patient -preferred and patent protected pharmaceutical products for global markets. Dimerix is currently developing its product DMX-200 for both Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis (FSGS). DMX-200 was identified using Dimerix’ proprietary assay, termed Receptor -Heteromer Investigation Technology (Receptor -HIT), which i s a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities.

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