Potential New Treatment Could Help Save COVID-19 Patients

A new anti-inflammatory drug developed by University of Queensland scientists based at TRI, has entered a Phase II clinical trial in COVID-19 patients in 10 to 15 hospitals across the USA.

The drug, IC14, is the lead therapeutic compound for Brisbane and Seattle-based biotech company, Implicit Bioscience, which was co-founded by TRI founder and The University of Queensland Diamantina Institute's Professor Ian Frazer AC.

Professor Frazer, said as the world welcomes COVID-19 vaccine candidates and a widespread prevention strategy, it remains vital to develop viable treatments that can help people who experience a life-threatening response to the virus.

“The emergence of new viral strains that may be resistant to current vaccines and drugs highlights the pressing need for interventions to help people during the early stages of COVID-19 respiratory disease,” he said.

“IC14 represents a world-first approach to treating the effects of COVID-19 and we are energised by the opportunity to participate in this important study.

“We hypothesise, from previous IC14 research in patients with sepsis and lung injury, that the investigational drug will help to control damaging levels of immune response to the viral infection. IC14 targets CD14, a master regulator of the immune response to infection and cellular damage, which is implicated in more than 500 diseases.”

The clinical trial, called the COVID-19 and Anti-CD14 Treatment Trial ("CaTT" NCT04391309), is sponsored and funded by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health.

NIAID Director, Dr Anthony S. Fauci, said: “By blocking a protein called CD14 during the early stages of COVID-19 respiratory disease, the monoclonal antibody IC14 could potentially temper the immune system’s harmful inflammatory responses to SARS-CoV-2, thereby limiting associated tissue damage and improving patients’ health outcomes.”

Implicit Bioscience will supply IC14 for the CaTT study, which will test the safety and efficacy of the investigational drug for treating hospitalised COVID-19 patients with respiratory disease and low blood oxygen in combination with the antiviral drug remdesivir (Veklury®, Gilead Sciences).

Implicit Bioscience CEO, Garry Redlich, said this clinical milestone is part of a calculated body of research being undertaken to unlock the potential of IC14. Right now, it is also being studied in 125 COVID-19 patients with respiratory distress in 20 US hospitals using the I-SPY clinical trial platform (NCT04488081), established by Quantum Leap Healthcare Collaborative.

"Between these two studies, IC14 will be studied in more than 400 COVID-19 hospitalised patients across the USA, across the full spectrum of disease, from the medical ward to the intensive care unit,” said Mr Redlich.

"We are deeply honoured to have our immunotherapeutic antibody sponsored for such comprehensive clinical testing during the global pandemic and look forward to leveraging our learnings for a broad range of potential disease indications for this promising biologic drug.”

The drug targets protein CD14, found on the outside of cells, and is a master regulator of the immune response to injury and infection. By blocking CD14, IC14 dampens the immune system’s proteins which are responsible for inflammation, reducing the potential for multi-organ failure in COVID-19 patients.

Professor Frazer said the drug: "switches off one part of the immune pathway which causes trouble rather than benefit … anywhere where chronic damage is produced by inflammation.

"It's an antibody, so it's infused into the bloodstream and basically it targets the molecule on the surface of one of the white blood cells that’s particular target is a key regulator of inflammation, and if we block that pathway then the inflammation dies down.”

Throughout the trial, IC14 will be administered to Americans admitted to hospital with COVID-19 as part of two separate studies. The drug will be administered to more than 300 patients, either already on ventilators and admitted to intensive care units or before they are ill enough for the ICU.

"The patients will get all the conventional treatments — they'll get steroids, they'll get antiviral drugs but then, in addition to them, some of them will be given this drug to see if it helps them get over the problem," Professor Frazer said.

If successful, the drug could become part of routine care for COVID-19 as well as any disease that causes severe long-lasting inflammation. 

Please see media release issued by the US National Institute of Allergy and Infectious Diseases (NIAID) HERE.