1st Patient Dosed in DMX-200 Clinical Trial for FSGS
2018-11-22 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗
For Immediate Release DIMERIX DOSES FIRST PATIENT IN DMX-200 CLINICAL TRIAL FOR FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) • First FSGS patient dosed with DMX-200 at Princess Alexandra clinical study site in Brisbane, Queensland; • Study enrolling across multiple Australian sites ; • Closely follows first patient dosed in Dimerix’ Phase 2 trial in Diabetic Kidney Disease , announced earlier this week; • Preliminary results anticipated during Q4 of calendar year 2019. MELBOURNE, Australia, 22 November 2018: Dimerix Limited (ASX: DXB) today announced that the first patient has been dosed in the Company’s Phase 2a clinical study of DMX-200 for Focal Segmental Glomerulosclerosis (FSGS) , a type of Chronic Kidney Disease . The patient was dosed at the clinical study site at Princess Alexandra Hospital in Brisbane, Queensland , as overseen by Study Investigator David Mudge, and occurred in line with anticipated timelines. FSGS is a serious and rare kidney disease that attacks the kidney’s filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and kidney failure . It affects at least 210,000 people globally 1 and is a disease for which there is a recognised m edical need for a new or improved treatment. DMX-200 has received Orphan Drug Designation in both the US and Europe for the treatment of FSGS. Dr Nina Webster , CEO of Dimerix said: “FSGS is a kidney disease that progresses rapidly and ultimately results in kidney failure, requiring dialysis or kidney transplant. There are over 95,000 patients currently on the kidney transplant waiting list in the US alone. Dimerix is committed to the pursuit of an effective treatm ent for FSGS as it is desperately under-served by existing therapies”. “We are very pleased to share the news that patient recruitment is progressing well and dosing for the FSGS trial has commenced . Dimerix is encouraged by the interest expressed by FSGS patients at study clinics to participate in the trial of DMX -200, as shown by the number of patients at various stages in the screening process. With both our FSGS and D iabetic Kidney Disease trials dosing patients, the Company has reached a key inflection point. We look forward to providing further market updates as the study progress”. The study will enroll 10 eligible patients across Australia, who will receive two treatment blocks of 16 weeks (separated by a six week washout period) during which patients will receive either placebo 1 Transparency Market Research, 2018, Focal Segmental Glomerulosclerosis (FSGS) Market, Global Industry Analysis, Size, Share, Growth, Trends, & Forecast 2017 -2025, [ONLINE] Available at: https://www.transparencymarketresearch.com/focal-segmental- glomerulosclerosis-market.html [accessed 21Nov18) 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 proteinuria , 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 clinical study of DMX-200 for Diabetic Kidney Disease , for which the first patient was dosed earlier this week . The two clinical 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, and patient dosing has occurred in line with anticipated timelines. Subject to patient recruitment rates, Dimerix reaffirms that preliminary results for both studies are anticipated 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 is 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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