India-based biologicals specialist Biocon received approval on 11 July 2020 from the Drug Controller General of India to market itolizumab (ALZUMAb®) injection 25 mg/5 mL solution for the emergency treatment of patients hospitalised with moderate to severe ARDS due to COVID-19 in India. This decision was based on results from Biocon’s randomized controlled trial in which the primary endpoint of one-month mortality and other efficacy endpoints, including clinical markers of inflammation, were statistically significant in favour of the itolizumab arm.

Itolizumab is an anti-CD6 monoclonal antibody that Biocon launched in 2013 for the treatment of chronic plaque psoriasis.

‘As itolizumab has been approved in India and given that we are in the middle of a medical emergency, the regulator has approved Biocon’s product for emergency use based on compelling data from a pivotal clinical trial involving a cohort of 30 patients’, says Kiran Mazumdar-Shaw, Executive Chairperson, Biocon.

South Korean biotechnology company Celltrion, in partnership with the University of Oxford and University Hospitals Birmingham, is investigating the use of its infliximab biosimilar CT-P13 as a treatment for COVID-19 symptoms in the phase II CATALYST trial [1].

Infliximab (Remsima®) is an anti-tumour necrosis factor (anti-TNF) therapy which is currently used as a treatment for inflammatory conditions. As severe COVID-19 infection is associated with a major inflammatory response, researchers are testing the theory that existing therapies targeting this could be used as a treatment for COVID-19 infection.

‘Using a treatment which is effective by blocking TNF in more than 10 inflammatory diseases to treat inflammation associated with COVID-19, in which levels of TNF are also high, makes a lot of sense’, said Sir Marc Feldmann, Professor of Immunology, University of Oxford. ‘If treated with infliximab upon admission to hospital, the number of patients who may need to be admitted to intensive care may be reduced’.

The CATALYST trial is an open-label, multi-arm, multi-stage trial taking place across 12 sites in the Midlands with the overall aim of assessing the efficacy of targeted drugs which can then be considered for larger-scale testing using one of the current national platform trials (RECOVERY or REMAP-CAP). This arm of the trial will evaluate whether treatment with CT-P13 is linked to improved oxygen saturation levels.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. COVID-19 drug trials underway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 2]. Available from: www.gabionline.net/Pharma-News/COVID-19-drug-trials-underway

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