4 June 2020
Global platform trial taps Australian drug for major global COVID-19 treatment study
As the world mobilises to bring to bear the full scientific resources it can to fight the COVID-19 pandemic, an Australian biotech company has been specifically tapped by the Global REMAP-CAP Platform Trial, a study endorsed by the World Health Organisation (WHO), for its expertise in inflammatory treatment.
The pandemic has spawned a wide range of clinical trials, but the WHO has endorsed the most promising as Pandemic Special Studies, which are designed to test a variety of treatments. The Australian Securities Exchange-listed Dimerix Limited has been brought into one of these global Pandemic Special Study protocols, to study the effect of its DMX-200 drug candidate in COVID 19 patients.
Dimerix’s lead product, DMX-200, is currently in two different Phase 2 clinical trials in patients suffering from two different types of chronic kidney disease. For one of those diseases, known as Focal Segmental Glomerulosclerosis (FSGS), DMX-200 has “orphan drug designation” in both the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA), a status granted to support and incentivise the development of products for rare diseases.
DMX-200 works against these kidney diseases by reducing inflammation damage, which promotes the progression of chronic kidney disease. It does this by blocking the “signalling” process by which inflammatory cells damage the kidney, including by limiting the onset of fibrosis (permanent scarring).
The relevance of this to COVID-19 – and the reason why the REMAP-CAP research team is working with Dimerix to bring DMX-200 into the study protocol – is that one of the hallmarks of severe cases of COVID-19 is acute respiratory distress syndrome (ARDS) that also manifests as a rapid, widespread inflammation of the lungs that can lead to respiratory failure and death.
ARDS is caused by the human immune response to the virus: based on the known effects in the lung of COVID-19, it is possible that DMX-200 may also benefit ARDS patients with COVID-19 by reducing the inflammatory response in the lungs, and thus reducing inflammation and subsequent scarring.
The REMAP-CAP Pandemic Special Study designation ensures that results of any clinical trial are communicated directly with policymakers and public health officials around the world for rapid implementation into clinical practice if required. REMAP-CAP has been named by the Chief Medical Officers of the United Kingdom as a key clinical trial for COVID-19.
The overall REMAP-CAP study plans to include more than 7,000 patients from over 200 study sites across Asia-Pacific, Europe and North America. The REMAP-CAP study already has treatments in the anti-viral, immune-modulation and immunoglobulin sphere. REMAP-CAP is now working with Dimerix to prepare a new treatment group to include DMX-200, and to rapidly obtain the necessary regulatory paperwork, before providing DMX-200 to sites from its existing drug supply.
The DMX-200 part of the study is expected to compare the treatment effect of DMX 200, alongside other study treatment options, on the clinical outcomes of COVID-19 patients requiring hospitalisation.
“We are extremely pleased to be in a position to support this global initiative investigating the potential of multiple therapies to treat COVID-19 patients dying of acute respiratory distress syndrome (ARDS),” said Dr Nina Webster, chief executive officer and managing director of Dimerix. “Dimerix is in a uniquely positioned to support the global effort in identifying COVID-19 treatments, as well as having two Phase 2 kidney clinical studies due for completion in mid-2020.”
This global study is supported by several funding agencies worldwide, with Dimerix expecting to be responsible for providing the DMX-200 study drug to the trial sites and supporting the REMAP-CAP team.
Monsoon Communications Tel: +61 (0)3 9620 3333
Dr Nina Webster, Dimerix Limited
Chief Executive Officer & Managing Director
Tel: +61 1300 813 321
Full media release here