DMX-200 for COVID Pneumonia Respiratory Complications Current Status: Phase 3

DMX-200 for COVID respiratory complications is currently in two Phase 3 clinical trials.

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

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

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.

COVID Pneumonia

The SARS coronavirus-2 emerged in late 2019, causing the coronavirus disease 2019 (COVID-19). COVID-19 can cause lung complications such as pneumonia and, in the most severe cases, acute respiratory distress syndrome (ARDS).

In pneumonia, the lungs become filled with fluid and inflamed, limiting their ability to take in oxygen, causing shortness of breath and coughing, which may lead to breathing difficulties. In some people with COVID-19, the immune system releases immune messengers, called cytokines, into the bloodstream out of proportion to the threat or long after the virus is no longer a threat. When this happens, the immune system attacks the body’s own tissues. This is called a “cytokine storm”. A cytokine storm triggers an exaggerated inflammatory response that may cause significant damage to the lungs.

While most people recover from pneumonia without any lasting lung damage, the pneumonia associated with COVID-19 can be severe. Even after the disease has passed, lung injury may result in breathing difficulties that might take months to improve.

  • ~15% of individuals with COVID-19 develop moderate to severe disease and require hospitalisation and oxygen support.
  • >3 million deaths caused by COVID-19.
  • >3 million deaths per year caused by non-COVID-19 pneumonias.
  • 20-30% of all pneumonias require admission to an Intensive Care Unit and supportive therapies including intubation and ventilation.

There is still no specific antiviral treatment for COVID-19 infection, only supportive therapies including respiratory care for affected patients, especially in more severe cases. If DMX-200 does show some benefit in respiratory complications associated with COVID-19, it may also show benefit in respiratory complications associated with other infections too.

For more information on Investment opportunities with Dimerix, visit the online Investment Centre