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COVID-19 drug trials underway Posted 10/07/2020

There are over 200 trials for COVID-19 currently in progress. These include trials of monoclonal antibodies, including from the South Korean firm Celltrion, as well as vaccines, notably from the Chinese firm CanSino Biologics.

Since the outbreak of the COVID-19 pandemic, companies around the world have been working to find an effective treatment for the disease. Gilead Sciences for example has been working to repurpose its existing anti-viral drug remdesivir, and recently signed agreements with generics manufacturers to increase production [1].

A recent report [2] estimates there are at least 232 treatment and vaccine trials for COVID-19 currently underway, roughly two thirds of which are already in phase II or phase III of testing. Therefore, results from many of these trials are expected soon.

Of the drugs being tested, many are biologicals, specifically antibodies. Tocilizumab, for example, is a monoclonal antibody which targets IL-6, an inflammatory cytokine. Tocilizumab is conventionally used to treat inflammatory conditions such as rheumatoid arthritis; but has been approved in China for the treatment of COVID-related inflammation.

Eleven trials are evaluating the use of tocilizumab to treat COVID-19, which will all be completed in the summer. These include a trial by Genentech, whose product Actemra significantly reduced the need for ventilation in an already completed phase II trial.

Eli Lilly meanwhile have developed Ly-CoV555, a neutralizing antibody against the SARS-CoV-2 spike protein (which mediates attachment to host cells and is therefore critical for infectiousness). Clinical tests of Ly-CoV555 began in June 2020. Virus neutralizing antibodies are also being developed by Vir Biotechnology and partner GlaxoSmithKline, and Regeneron Pharmaceuticals, both based in the US.

The South Korean firm Celltrion has also reported positive results for an antibody candidate. In June 2020, the company reported data demonstrating a reduction in viral load, reduced inflammation in the lung tissue of animal models, and a shortened recovery time. The first clinical trials of the drug are expected to begin in July 2020.

Ki-Sung Kwon, Head of R & D at Celltrion, said in a statement: ‘Celltrion is leveraging its advanced technologies to lead efforts to develop a novel antiviral antibody treatment containing potent therapeutic antibodies that can neutralise the virus. Celltrion hopes to commence first-in-human clinical trials in July 2020 and has the capability to roll out mass production of the therapeutic antibody treatment once it is ready.’

Celltrion are also trialling their existing anti-inflammatory molecule CT-P13, a biosimilar of infliximab [3], to treat COVID-19 symptoms. It is thought the drug could target the harmful inflammatory response seen in severe cases of COVID-19.

A trial in partnership with the University of Oxford and University Hospitals Birmingham in the UK will take place across 12 sites. If a potential benefit is shown, larger scale clinical trials would be required.

In terms of vaccines in development, the current front runners are from Moderna, headquartered in the US, and CanSino Biologics, headquartered in China. Both companies have released results demonstrating the production of virus neutralizing antibodies in healthy volunteers. Results are soon expected from an additional eight vaccine candidates.

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References
1. GaBI Online - Generics and Biosimilars Initiative. COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Generics/News/COVID-19-drugs-Gilead-s-remdesivir-and-Algernon-s-alternative
2. Koch S. Over 200 COVID-19 trials nearing completion should provide a busy summer of data readouts. BioCentury. Jun 5 2020.
3. GaBI Online - Generics and Biosimilars Initiative. Real-world data confirms safety of infliximab biosimilar CT-P13 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/Research/Real-world-data-confirms-safety-of-infliximab-biosimilar-CT-P13

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