- Dimerix has completed enrolment for the phase 2 study of its drug DMX-200 — aimed at treating diabetic kidney disease
- The endpoint of the study is to reduce albuminuria (protein in urine) compared to those who haven’t taken the drug
- The study is expected to be completed in the second quarter of the 2020 calendar year
- Plans for the commercialisation phase of DMX-200 are also underway
Biopharmaceutical company Dimerix has completed enrolment for its phase 2 study of drug DMX-200 — aimed at treating diabetic kidney disease.
The primary endpoint for the study is the reduction in albuminuria (protein in urine) compared to those who haven’t taken DMX-200.
An independent review of the drug gives the company hope for significant results during the trial.
The trial will be double-blind, randomised, placebo-based and control based.
Each participant will receive 12 weeks of DMX-200 and 12 weeks placebo. This will be separated by a six week washout period.
No safety concerns have been reported to date and Dimerix expects to complete the study in the second quarter of the 2020 calendar year.
This study will follow on from the successful phase 2a study completed in 2017 that used patients with a range of chronic kidney diseases.
All primary and secondary endpoints were met and the trial showed particularly compelling efficacy in the sub-group of patients with diabetic kidney disease.
DMX-200 inhibits the activity of cellular receptors which cause inflammation. It is being developed for treating diabetic kidney disease and kidney damage.
The current standard of care treatment, Irbesartan, has shown to reduce proteinuria (excess protein in urine) levels by 24 per cent in type 2 diabetics.
When taken with DMX-200, proteinuria levels decreased by a further 36 per cent.
In 2017 there were 23 million diagnosed diabetics in the U.S. and incidents of diabetes are expected to grow 54 per cent by 2040.
Approximately 20 per cent of all diabetics suffer from kidney disease which can lead to kidney failure.
These is no current cure for diabetic kidney disease and the current treatment options are ineffective as kidneys are deteriorate towards failure.
Current treatment options include medications or transplants. However, these can be costly and take a lot of time and energy from the patient.
Simultaneously, with these trails Dimerix is continuing with activities to support future regulatory submissions which include the manufacturing validation and commercial scale up of activities.
Plans for the commercialisation phase are also underway.