- Protocols for an international study into COVID-19 therapies including Dimerix’s (DXB) DMX-200 drug have been published
- REMAP-CAP is a World Health Organisation-endorsed (WHO) study into therapies treating acute respiratory distress syndrome (ARDS)
- ARDS is the leading cause of death associated with COVID-19
- With the publishing of the study protocols, Dimerix is a step closer to testing its lead ARDS therapy on the global stage
- If successful, it may also be effective in other associated infections like the flu and pneumonia, significantly expanding the addressable market for the drug
- Dimerix is hopeful the study will support independent new drug (IND) submissions in the U.S., Europe, the U.K. and Canada
- Dimerix is trading 3.77 per cent higher for 27.5 cents
Protocols for an international study into COVID-19 therapies including Dimerix’s (DXB) DMX-200 drug have been published.
The study
REMAP-CAP is a World Health Organisation-endorsed (WHO) study into therapies minimising acute respiratory distress syndrome (ARDS) — the leading cause of COVID-19-related deaths.
The randomised, open label study will enrol patients admitted to hospital with acute illness due to suspected or proven COVID-19.
The study will test a several therapies both alone and in combinations to investigate the effects on in-hospital mortality as well as the number of days on a respirator up to three weeks after treatment.
The study is designed to be flexible, so when positive data is returned in a cohort of patients, the treatment can be rapidly extended into additional trial sites around the world.
There is, therefore, no fixed number of patients to be enrolled, however, there are a number of interim analyses built into the protocol to assess patients assigned to DMX-200, so Dimerix will have a good handle on the efficacy of its therapy.
DMX-200 is aimed at reducing damage from inflammatory immune cells by blocking their signalling. It’s believed this may inhibit subsequent movement into the lungs or other tissues damaged by the virus.
Next steps
Dimerix is hopeful the study will support independent new drug (IND) submissions in the U.S. and other jurisdictions including Europe, the U.K. and Canada.
The company has already manufactured the required pharmaceutical-grade medication for use in the trial and is ready to ship to those countries that will first initiate treatment.
REMAP-CAP RAS Domain Specific Working Group Chair Dr Patrick Lawler says DMX-200 offers some promise in the treatment of the symptoms of COVID-19.
“There is a compelling biologic rationale to imbed DMX-200 into the […] REMAP-CAP COVID trial, where its potential therapeutic effects may […] reduce the organ support requirements, including ventilation, and death in patients hospitalised with COVID-19,” Dr Lawler said.
Dimerix CEO and Managing Director Dr Nina Webster says the company is glad to be included in the trial.
“We acknowledge the time and effort that the REMAP-CAP team have spent in preparing a well-designed and robust clinical study domain to assess the effect of our compound in these patients,” Dr Webster said.
“We have now completed three Phase two studies that show efficacy in a group of patients with active inflammatory disease and are all supportive of our inclusion in this ARDS study as well as progressing DMX-200 into a Phase three clinical study in Focal Segmental Glomerulosclerosis (FSGS) in the first half of 2021.”
If DMX-200 proves effective in the treatment of ARDS in COVID-19 patients, it may also be effective in other associated infections like flu and pneumonia, significantly expanding the addressable market for the drug.
Dimerix is trading 3.77 per cent higher for 27.5 cents at 12:50pm AEDT.