A lead drug candidate developed by clinical-stage biopharmaceutical company Dimerix Limited (ASX: DXB) has been selected for inclusion in a global study aimed at treating patients with acute respiratory distress syndrome (ARDS) as a result of COVID-19.
The randomised, embedded, multifactorial adaptive platform trial for community-acquired pneumonia (or REMAP-CAP) program will focus on a number of diverse interventions in hospitalised patients with proven or suspected COVID-19, enrolling in intensive and non-intensive care unit settings.
Dimerix’s development drug DMX-200 was selected for its potential to benefit patients with ARDS by reducing the inflammatory response in the lungs and decreasing inflammation and subsequent fibrosis.
Subject to regulatory and ethics approvals, Dimerix will supply quantities of the drug from its existing pharmaceutical grade manufactured supply.
The company has lodged provisional patent applications in addition to its existing granted patents in all key jurisdictions for use of any CCR2 inhibitor, including DMX-200, for the treatment of ARDS.
Chief executive officer Dr Nina Webster said Dimerix was keen to support global COVID-19 treatment efforts.
“This trial could potentially have a tremendous clinical impact for a condition with high morbidity and mortality and for which few effective therapies are available,” she said.
“We are extremely pleased to be in a position to support the initiative to investigate multiple therapies for patients dying of ARDS.”
Designated as a Pandemic Special Study, REMAP-CAP is being led by a network of experts, institutions and research groups and has been endorsed by the World Health Organisation.
The designation ensures that knowledge translation of clinical trial results can occur directly with policymakers and public health officials for rapid implementation around the globe as required.
The study has been named by the UK’s chief medical officers as a key clinical trial for COVID-19.
While actual numbers are not specified at the outset of adaptive studies, there are plans to include over 7,000 patients at 200 already-initiated study sites across the Asia-Pacific, Europe and North America.
Patients hospitalised with COVID-19 typically develop acute lung dysfunction due to the human immune response to the virus.
It is widely accepted that the illness will result in chronic lung fibrosis similar to previous contagious coronavirus infections such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
These complications can lead to poor quality of life, high ongoing hospitalisation requirements and ultimately a poor prognosis.
REMAP-CAP has several existing treatment domains including anti-viral, immune-modulation and immunoglobulin treatment arms.
Researchers are actively developing a new domain to study the effects of renin angiotensin system inhibition, which includes DMX-200.
“Our drug has been selected based on the strong scientific rationale and unique potential to treat COVID-19 related issues,” Dr Webster said.
“Upon regulatory approval, it could be the only investigational new drug in the study since all of the other selected candidates are a repurposing of existing approved drugs with potential for COVID-19.”
DMX-200 was originally developed as a renal therapy to reduce damage from inflammatory cells by blocking their signalling and limiting the onset of fibrosis.
The process was discovered in a laboratory at the Harry Perkins Institute of Medical Research and the University of Western Australia.
Dimerix has two further phase two studies currently underway for diabetic kidney disease and focal segmental glomerulosclerosis, a disease in which scar tissue develops on the parts of the kidneys that filter waste from the blood
The company also has a new asset in pre-clinical development known as DMX-700 for the treatment of chronic obstructive pulmonary disease.
At mid-morning, shares in Dimerix were trading 70.37% higher at $0.46.