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Brisbane and Seattle-based biotechnology company Implicit Bioscience has launched a Phase 2 clinical trial of its lead immunotherapy product to treat COVID-19 patients.
Implicit Bioscience, co-founded by renowned immunologist Professor Ian Frazer, will test the efficacy and safety of IC14 for treatment of hospitalised COVID-19 patients with respiratory disease and low blood oxygen in combination with the antiviral drug remdesivir.
The trial, called the COVID-19 and Anti-CD14 Treatment Trial (CaTT), is sponsored and funded by the US National Institute of Allergy and Infectious Diseases (NIAID).
IC14, wholly owned by Implicit Bioscience, is a monoclonal antibody that works by dampening damaging levels of immune response to viral infections that result in respiratory distress and serious damage to the patient's lungs, heart, kidneys, brain and other organs.
It targets CD14, a master regulator of the immune response to infection and cellular damage, that is implicated in more than 500 diseases.
Professor Frazer says 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," says Professor Frazer, the co-inventor of the cervical cancer vaccine.
"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, that is implicated in more than 500 diseases."
That hypothesis is supported by NIAID director Dr Anthony Fauci.
"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," Dr Fauci said.
The Phase 2 clinical trial is part of a broader body of research being undertaken to unlock the potential of IC14.
IC14 is currently being studied in 125 COVID-19 patients with respiratory distress in 20 US hospitals.
"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," Implicit Bioscience CEO Garry Redlich said.
"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 CaTT study will enrol between 300 and 350 hospitalised COVID-19 patients aged 18 years or older at 10 to 15 sites in the US. All participants will also receive intravenous infusions of the antiviral drug remdesivir for five consecutive days.
Results are expected in early 2022.
Implicit's trial follows in the footsteps of another immunotherapeutic approach to treating COVID-19 developed by Immutep.
The company is currently in the randomised portion of its EAT COVID trial, which is looking to see whether an experimental cance drug can boost the body's immune response while fighting off a COVID-19 infection.
Updated at 2.55pm AEST on 16 April 2021.
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