Gilead's Remdesivir Shows Promise in Taming Coronavirus

Gilead Sciences’ (Foster City, CA, USA) has begun conducting phase III studies for evaluating the safety and efficacy of its antiviral drug, remdesivir in adults diagnosed with COVID-19.

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, but is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19. Remdesivir has also shown promising results in the treatment of COVID-19 of 14 coronavirus-infected patients in Japan. However, remdesivir is an experimental medicine that has only been used in a small number of patients with COVID-19 to date, and hence Gilead does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time.

Following the US Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing, the company has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19. These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March 2020. The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing regimen of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, as compared to standard of care alone.

Additionally, health authorities in China have initiated two clinical trials in patients who have been infected with COVID-19 to determine the safety and efficacy of remdesivir as a potential treatment for the coronavirus. One study is evaluating remdesivir in patients with confirmed disease who have developed more severe clinical manifestations, such as a requirement for supplemental oxygen. The other study is evaluating remdesivir in patients with confirmed COVID-19 infection who have been hospitalized but are not displaying significant clinical manifestations of disease such as an oxygen requirement. The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has also initiated a Phase II adaptive, randomized, double-blind, placebo-controlled trial into remdesivir as a potential treatment for hospitalized adult patients diagnosed with COVID-19.

To increase available clinical supplies of remdesivir, Gilead is manufacturing two formulations of remdesivir, in both liquid and freeze-dried forms, expanding its network of manufacturing partners to increase capacity and production, and has begun internal manufacturing of remdesivir to supplement the capacity of the external manufacturing network. In anticipation of potential future needs, Gilead has accelerated manufacturing timelines to increase available supply as rapidly as possible. Gilead is doing this before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID-19.

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