Clinical-stage biopharmaceutical company Dimerix Limited’s (ASX: DXB) lead candidate DMX-200 is entering a second clinical study in COVID-19 patients led by Professor Meg Jardine (NHMRC Clinical Trials Centre at The University of Sydney, Australia) and conducted in collaboration with Professor Vivek Jha and The George Institute for Global Health (India).
The Dimerix candidate CCR2-inhibitor, DMX-200, was selected by the Lead Investigators of the Controlled evaluation of Angiotensin Receptor Blockers for COVID 19 respiratory disease (CLARITY) study, for a partner study, CLARITY 2.0, to evaluate DMX-200 treatment in patients diagnosed with COVID-19 who are intended for hospital admission.
Dimerix has entered into an agreement with the University of Sydney’s NHMRC Clinical Trials Centre (CTC) to initiate the investigator-led study, under which Dimerix will provide the DMX-200 and matched placebo study medication.
The CLARITY 2.0 vanguard (feasibility)/Phase 3 study will assess the safety and effectiveness of DMX-200 administered together with an angiotensin receptor blocker (ARB), on clinical outcomes of approximately 600 participants in India who have tested positive for COVID-19.
CLARITY 2.0 is a prospective, multi-centre, randomised, double blind, placebo-controlled study, with the primary endpoint being the 7-point clinical health score developed by the World Health Organization (WHO) for Coronavirus Disease 2019 (COVID-19) trials (scored from no hospitalisation or ventilation requirement through to death) at treatment day 14. Participants will be treated for up to 28 days and then followed up for a total of 26 weeks.
The DMX-200 therapy is aimed at reducing damage from inflammatory immune cells by blocking their signalling and limiting subsequent movement in the lungs, or other tissues, damaged by the virus. Global experts see DMX-200 as a compelling potential treatment option to limit inflammation in the lungs during infection of the SARS-CoV2 virus.
The SARS-CoV-2 virus downregulates and suppresses certain anti-inflammatory effects and that may tip the local lung environment towards inflammation and fibrosis and might be why the virus has such a devastating effect on lung tissue,” said Professor Meg Jardine.
“We generally see that people with chronic health conditions that include inflammatory drivers, such as chronic kidney disease, diabetes, cardiovascular disease and obesity, are also those who are more vulnerable to respiratory complications if they contract the SARS-CoV2 virus. Some of those inflammatory drivers interact with the blood pressure system which is why some common blood pressure medications may improve outcomes in COVID-19 disease.
“Early results suggest that DMX-200 may have stronger anti-inflammatory effects when used in combination with these blood pressure medications. The CLARITY and CLARITY 2.0 studies are designed to answer whether these blood pressure medications, used alone or in combination with DMX-200, may alter the course of COVID-19 disease and provide a better outcome for patients.”
Dimerix CEO and MD, Dr Nina Webster, said that unfortunately, the threat of COVID-19 outbreaks are likely to remain with us for some time.
“Our lead candidate, DMX-200, has demonstrated efficacy across three different studies in patients with active inflammatory disease, and we are very pleased to support a second research study in COVID-19 patients as well as progressing DMX-200 into a Phase 3 clinical study in the rare kidney disease Focal Segmental Glomerulosclerosis (FSGS) in the first half of 2021.
“Dimerix recognises and appreciates the support and collaboration of India within the expanse of research into SARS-CoV-2 and COVID-19. If, DMX-200 in combination with an ARB is proven effective for the treatment of COVID-19, and is approved for an indication within this setting, Dimerix is committed to an upscale of opportunity for treatment, including a fair and ethical supply of DMX-200 within India in line with industry standards.”
In September, Dimerix was awarded $1 million from the Australian Government’s Biomedical Translation Bridge (BTB) program to support the inclusion of DMX-200 in the REMAP-CAP global study in COVID-19 patients with ARDS, a more progressed and severe respiratory disease stage. REMAP-CAP is a global World Health Organization (WHO)-endorsed study designed to rapidly generate evidence for treatments in patients with respiratory distress associated with COVID-19.