EMBARGOED: 5:00am, Friday 16 April 2021
CLINICAL MILESTONE: Implicit Bioscience mobilises world-first immunotherapy in fight against COVID-19
Brisbane and Seattle-based drug developer, Implicit Bioscience, has reached an important clinical milestone in the development of its lead therapeutic candidate, IC14, for the treatment of gravely ill COVID-19 patients. IC14 is an investigational anti-CD14 monoclonal antibody.
Brisbane, Australia, 16 April 2021: Brisbane and Seattle-based biotechnology company, Implicit Bioscience Ltd, is pleased to announce its lead drug IC14 will be tested in a Phase 2 clinical trial in COVID-19 patients in 10 to 15 hospitals across the USA – which commenced this week. The 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.
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).
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 co-founder and Chief Scientific Officer, Professor Ian 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. 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,” said Professor Frazer.
“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.”
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.”
About the anti-CD14 Clinical Trial (CaTT)
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. Volunteer participants will be assigned at random to receive intravenous infusions of either IC14 or a placebo for four days. Neither the participants nor the study team will know who receives the monoclonal antibody or the placebo until the end of the trial. All participants will also receive intravenous infusions of the antiviral drug remdesivir for five consecutive days. The study team will follow participants for 60 days. Results are expected in early 2022. The primary endpoint is time to clinical recovery. Secondary outcome measures include days alive and free of respiratory failure. Please see media release issued by the US National Institute of Allergy and Infectious Diseases (NIAID) HERE.
IC14 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.
IC14 targets CD14, a master regulator of the immune response to infection and cellular damage, that is implicated in more than 500 diseases. IC14 is the only clinical-stage drug for this target and is wholly owned by Implicit Bioscience Ltd.
The drug is administered via intravenous infusion.
The original body of research for IC14 was conducted in the laboratory of Prof. Richard Ulevitch at Scripps Research (La Jolla, CA) more than two decades ago. As the understanding of the full spectrum of diseases driven by CD14 continues to grow, Implicit Bioscience is proud to be collaborating with Scripps and Prof. Ulevitch to deepen the scientific enquiry into the role of this unique target in the immune system.
In addition to COVID-19 ARDS, Implicit Bioscience is developing IC14 for the treatment of ALS-MND following successful early-stage trials in Brisbane and Boston. IC14 was recently granted Orphan Drug designation by the US FDA for the treatment of ALS-MND.
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Please see media release issued by the US National Institute of Allergy and Infectious Diseases (NIAID) HERE.
H^CK Director, Haley Chartres
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