According to a World Health Organization official, Gilead's experimental antiviral drug remdesivir, to date, shows the most promise for treating COVID-19 disease.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity. Although it is not currently approved for 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.
Gilead has initiated two Phase III trials to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. FDA’s rapid review and acceptance of Gilead’s investigational IND filing. These studies will enroll approximately 1,000 patients primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases.
The first of two studies will evaluate both a 5-day and a 10-day dosing regimen of remdesivir for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy for patients with moderate manifestations of COVID-19, compared with standard of care alone.
Gilead is working with government and other organizations and regulatory authorities to provide remdesivir to patients with COVID-19 for emergency treatment in the absence of any approved treatment options.
There are currently limited available clinical supplies of remdesivir but Gilead is working to increase its available supply as rapidly as possible.
In response to the Ebola outbreaks in West Africa in recent years, Gilead increased manufacturing of remdesivir to create a stockpile of product that could be used in response to future pandemics, as well as a stockpile of materials used to manufacture remdesivir. Gilead is now using this stockpile to address the supply needed for current compassionate use requests and the two clinical trials in China.
In anticipation of potential future needs, Gilead has accelerated manufacturing timelines to increase available supply as rapidly as possible. Gilead is taking these actions before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID-19.
