Dimerix Limited announced 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.