Australian clinical-stage biopharmaceutical company Dimerix (ASX:DXB) has announced that its DMX-200 has been selected for inclusion in the protocol as a new treatment arm in a clinical trial for Acute Respiratory Distress Syndrome (ARDS) as a result of COVID-19.
The Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) program is endorsed by the World Health Organisation (WHO) and designated as a Pandemic Special Study.
REMAP-CAP (and the companion platform REMAP-COVID) is an international adaptive platform trial run by a network of leading experts, institutions and research groups. The program is studying a number of interventions in hospitalised patients with proven or suspected COVID-19, enrolling in both ICU and non-ICU settings.
The study has several existing treatment domains including anti-viral, immune-modulation and immunoglobulin treatment arms.
"This 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," said the company in a statement.
"It ensures that results generated from REMAP-CAP during a declared pandemic can be translated in an efficient and transparent manner to benefit affected patients, providing a collaborative pathway to global clinical practice. Furthermore, REMAP-CAP has been named by the Chief Medical Officers of the United Kingdom as a key clinical trial for COVID-19."
REMAP-CAP includes a domain to study the effects of renin-angiotensin system inhibition, which includes DMX-200. The study aims to compare the effect of a number of study options on the clinical outcomes of COVID-19 patients requiring hospital care.
"Upon regulatory approval, DMX-200 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," said the company.
“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 ARDS,” said Dr Nina Webster, CEO and managing director of Dimerix. “Dimerix is uniquely positioned to support the global effort in identifying COVID-19 treatments, as well as having two Phase 2 renal clinical studies completing mid-2020.”