LAST PATIENT COMPLETES DOSING IN DIMERIX DIABETIC
KIDNEY DISEASE PHASE 2 CLINICAL STUDY
• Last patient in Phase 2 clinical study of DMX-200 in diabetic kidney disease patients has
received last dose
• Top line results expected in approximately 4 - 6 weeks
• FSGS study top line results anticipated prior to end July 2020
MELBOURNE, Australia, 24 July 2020: Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical
company, is pleased to advise that the last patient has completed dosing in its clinical study in diabetic
kidney disease, and all critical data to determine efficacy has been collected. No safety concerns have
been expressed by the Data Safety Monitoring Board to date and Dimerix expects to provide top line
results for the study in approximately 4-6 weeks, pending database lock.
The Phase 2 study is a double-blind, randomised, placebo-controlled, crossover study designed to
evaluate the safety and efficacy of DMX-200 in patients with diabetic kidney disease who are receiving
a steady dose of an angiotensin receptor blocker, irbesartan. As previously announced, each
participant in the study received 12 weeks DMX-200 and 12 weeks placebo, separated by a minimum
6-week washout period. The study is statistically powered to resolve a 30% reduction in proteinuria,
based on 40 patients completing the study in line with the protocol.
The primary endpoint for the study is the percent change from baseline in 24-hour albumin to
creatinine ratio after 12-weeks of treatment with DMX-200 as compared to placebo in participants
with diabetic kidney disease who are receiving irbesartan.
The secondary endpoints include efficacy measures such as the frequency of patients who achieve an
albumin reduction of 30% or more, and other key kidney function parameters, as well as the safety
profile of DMX-200 compared to placebo.
Importantly, Dimerix has facilitated continued compassionate access to DMX-200 for multiple
patients who have completed the study via their physician through the TGA Special Access Scheme.
There were 23 million diagnosed diabetics in the US in 2017, and the incidence of diabetes is estimated
to grow by 54% by the year 2040. Approximately 40% of all diabetics suffer from kidney disease, which
is a progressive disease leading to kidney failure and dialysis, and many do not know it yet. There is
no cure for diabetic kidney disease, and current treatment options are ineffective as the kidneys
deteriorate towards failure. The current treatment options include medications to reduce high blood
pressure, dialysis or kidney transplant. The progressive nature of kidney disease inevitably results in
poor outlook for patients, as it most often results in total kidney failure and a poor quality of life.
Dialysis costs are in the region of $100,000 per patient per year and requires in excess of 12 hours per
week in regular clinic visits. Alternatively, 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.
These options are a huge burden on both the patient and the healthcare system. DMX-200 has the
potential to significantly increase the life of the kidney, reducing the burden for both the patient and
the healthcare system.
Dimerix has two Phase 2 studies underway: DMX-200 for FSGS (top line data anticipated by end July
2020; and DMX-200 for Diabetic Kidney Disease, an asset in pre-clinical development, DMX-700 for
chronic obstructive pulmonary disease (COPD), and a pivotal phase opportunity: DMX-200 in Acute
Respiratory Distress Syndrome (ARDS) in patients with COVID-19.
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]
Rudi Michelson
Monsoon Communications
Tel: +61 3 9620 3333
Mob: +61 (0)411 402 737
E:
[email protected]
(20min delay)
