DMX-200 in COVID-19 Respiratory Complications
As the virus causing COVID-19 enters the lung, the human immune system invites inflammatory cells to the lungs, causing a feedback loop that results in fibrosis, or scarring of the lung tissue which floods the lungs. The Dimerix drug candidate, DMX-200, may work by reducing the damage caused – by dialling down the immune response, and therefore preventing the flooding and lung damage.
By limiting the inflammation and reducing the damage caused by the virus, DMX-200 may reduce the severity and duration of those symptoms associated with COVID-19 disease, as well as reduce the long-term impact and health burden once patients leave hospital.
DMX-200 is in two Phase 3 studies in COVID-19 patients:
REMAP-CAP global study is an investigator-led feasibility/Phase 3 study in patients with COVID-19 pneumonia, driven by a consortium of global trialists, clinicians and experts through the study sponsor, REMAP-CAP. The study, endorsed by the World Health Organization (WHO), has initiated a master protocol across over 300 clinical sites across eight global regions. REMAP-CAP currently investigates over 20 active treatments for COVID-19. The study has now recruited over 6,000 patients with suspected or proven COVID-19 overall. The study intends on treating >200 patients with DMX-200.
Importantly, REMAP-CAP is predominantly funded by the European Union through the H2020 Project called “Rapid European COVID-19 Emergency Research response. In addition, Dimerix was awarded $1 million from the Australian Government’s Medical Research Future Fund to support inclusion of DMX-200 in this study.
CLARITY 2.0 is an investigator initiated, prospective, multi-centre, randomised, double blind, placebo-controlled study of DMX-200, commencing with 600 patients diagnosed with COVID-19. The primary endpoint is a 7-point scale of clinical health at treatment day 14, adapted from the endpoint recommended by the WHO for COVID-19 trials (scored from no hospitalisation or ventilation requirement through to death). Participants will be treated for up to 28 days and then assessed for clinical outcomes for a total of 26 weeks.
The study is being run through the NHMRC Clinical trials centre and the University of Sydney.