Dimerix Limited announced additional positive efficacy data from the Phase 2 study in diabetic kidney disease patients that reported top line data in September 2020, looking at the overall treatment effect in patients at the end of the cross-over study, as well as plans to further progress development of DMX-200 in diabetic kidney disease. An exploratory subgroup analysis was conducted in patients during the second treatment period, where a 37% reduction in albuminuria in patients receiving DMX-200 versus placebo in those patients with a starting albuminuria baseline greater than 500 mg/g (38% reduction versus baseline; n=26). A 22% mean reduction in albuminuria was observed in patients on DMX-200 versus placebo when normalised to first baseline (27% reduction versus baseline; n=40). Importantly, these reductions in albuminuria are in addition to any reduction that occurred on the background therapy of an angiotensin receptor blocker. These data support the mechanism of action of DMX-200, which aims to reduce inflammation, being effective in diseases where active inflammatory processes are driving disease progression and are also consistent with Dimerix' observations from the prior open-label study (completed in 2017) where diabetic patients achieved a 36% reduction in albuminuria compared to baseline after 26 weeks of treatment with DMX-200. At the end of the current study, it was further noted that albuminuria levels appeared to be continuing to trend downwards at the end of both DMX-200 treatment periods, which also suggests greater albuminuria reductions may be observed with a longer study treatment duration. This is consistent with effects seen in other late-stage clinical studies including in Dapagliflozin (doi:10.1111/dom.12654), Canagliflozin (doi:10.1681/ASN.2020050723) and Finerenone (doi:10.1056/NEJMoa2025845) and in the previous Dimerix study of DMX-200 in patients with diabetic kidney disease completed in 2017. Importantly, other medications taken during the study, including SGLT2 inhibitors, did not appear to affect the efficacy outcomes of DMX-200. The Medical Advisory Board has now concluded its formal assessment of the Phase 2 renal data in diabetic kidney disease. Importantly, these encouraging data support the ongoing development of DMX-200 in diabetic kidney disease, and based on the Phase 2 data, a further study assessingthe effect of DMX-200 in diabetic kidney disease patients over a longer period is warranted. Given the effect of DMX-200 on albuminuria levels appears to be continuing to trend downwards, while the placebo does not, which is consistent with other studies in diabetic kidney disease patients, a longer study will allow the natural history of diabetic kidney disease patients to be contrasted against possible longer-term effects of DMX-200. Dimerix is now assessing the study design in diabetic kidney disease patients. The Phase 2 study was a double-blind, randomised, placebo-controlled, cross-over study designed to evaluate the safety and efficacy of DMX-200 in patients with diabetic kidney disease who were receiving a stable dose of standard of care, irbesartan. In this study, efficacy was measured by a surrogate biomarker of protein in the urine, known as albuminuria, and which is typically used as a measure of kidney disease progression. Higher levels of albuminuria are reflective of more advanced disease and an expectation of a faster decline in kidney function. Conversely, a reduction in the amount of albumin in the urine reflects a slowing of the progression of kidney failure. Dimerix is also pleased to report that the first patient with kidney disease to be treated with its drug candidate, DMX-200, on compassionate grounds (Therapeutic Goods Administration - Special Access Scheme) will celebrate four years of on-going treatment in February 2021. This patient received the first dose of DMX-200 under the Special Access Scheme in February 2017, has been on continuous therapy, and thus has apparent treatment related benefits since that time. Multiple kidney disease patients have since accessed DMX-200 under the Special Access Scheme. In parallel, Dimerix continues to undertake planning for the proposed Phase 3 pivotal program in FSGS, a rare kidney disorder without an approved pharmacologic treatment that often leads to end-stage kidney failure, as well as further progress two Phase 3 studies of DMX-200 in COVID-19 patients, and finally advance the COPD program towards the clinical stage of development.