GILEAD SCIENCES ANNOUNCES TWO PHASE 3 RANDOMISED STUDIES TO EVALUATE THE SAFETY AND ANTIVIRAL ACTIVITY OF REMDESIVIR (GS-5734™) IN PARTICIPANTS WITH MODERATE TO SEVERE COVID-19

Written by: PharmiWeb Editor
Published On: 1 Apr 2020

-- Remdesivir is an investigational agent – it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use.

-- The UK is one of the countries where Gilead is running clinical trials to evaluate remdesivir for the treatment of COVID-19

London, April 1st 2020 – Gilead Sciences announced today that the company has initiated two phase 3 randomised studies to evaluate the safety and efficacy of its investigational treatment remdesivir in patients with moderate to severe COVID-19 (coronavirus). The two studies which have been given urgent public health research (UPHR) status by the Chief Medical Office will initially involve 15 centres* in the UK.

“Gilead started research into remdesivir more than a decade ago. We are now in a position to consider its potential to treat COVID-19 and rapidly progress its development, and these clinical trials will help generate important data on the safety and efficacy of the medication in the coming weeks,” said Hilary Hutton-Squire, Vice President and General Manager, Gilead Sciences UK & Ireland. “Gilead is supporting clinical trials of remdesivir around the world, and we are grateful to the Medicines and

Healthcare products Regulatory Agency (MHRA), National Institute for Health Research (NIHR) and the Department of Health and Social Care (DHSC) for their support in getting these trials off the ground with such speed in the UK.”

Dr Siu Ping Lam, Director of Licensing Division of MHRA said: “The MHRA is ready to prioritise and provide any assistance for clinical trials and other regulatory applications in response to COVID-19, in line with government priorities. We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufacturers, researchers and other regulators. We have dedicated resources to ensure this happens, as we did during the Ebola crisis when we authorised clinical trial applications within a week.”

*Selected Sites

Liverpool University Hospitals NHS Foundation Trust, Royal Free London NHS Foundation Trust,

Sheffield Teaching Hospitals NHS Foundation Trust (adult services), Manchester Royal Infirmary,

Wythenshawe Hospital, Hull University Teaching Hospitals NHS Trust, London North West University

Healthcare NHS Trust, The Pennine Acute Hospitals NHS Trust, University College London Hospitals

NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, Royal Lancaster Infirmary,

Glasgow Queen Elizabeth University Hospital, Edinburgh Western General Hospital, University

Hospitals Plymouth NHS Trust, Imperial College Healthcare NHS Trust.

About Remdesivir

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity demonstrated both in vitro and in animal models against multiple emerging viral pathogens including Marburg, MERS, SARS, and more recently Ebola. The viral pathogens MERS and SARS are also coronaviruses and are structurally similar to the SARS-CoV-2 that causes COVID-19. As this is a new virus, there are no approved medicines and little clinical trial data with potential treatments. The limited preclinical data for remdesivir in MERS and SARS indicates that the medicine may have potential activity against SARSCoV-2. Remdesivir is an investigational agent – it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

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