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Gilead Sciences Updates (2-26) Company’s Ongoing Response to COVID-19 with Investigational Compound Remdesivir

In a February 26, 2020 report, Gilead Sciences said that it is working closely with global health authorities to respond to the novel coronavirus (COVID-19) outbreak through the appropriate experimental use of the investigational compound remdesivir (https://en.wikipedia.org/wiki/Remdesivir) (image). Together with the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), National Institute of Allergies and Infectious Diseases (NIAID) and Department of Defense (DoD) - CBRN Medical; the China CDC and National Medical Product Administration (NMPA); the World Health Organization (WHO); and individual researchers and clinicians; Gilead is focused on contributing its antiviral expertise and resources to help patients and communities fighting COVID-19. Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – it 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. This is an experimental medicine that has only been used in a small number of patients with COVID-19 to date, so Gilead does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time. Gilead’s response to COVID-19 entails three main areas. The first is clinical trials. Gilead-Initiated Trials: Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. 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 the 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, compared with standard of care alone.

OTHER TRIALS

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. The two studies are being coordinated by the China-Japan Friendship Hospital and are being conducted at multiple sites in China’s Hubei province. Gilead is providing study drug at no charge and has provided input on study design and conduct.
One of these studies 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 study in patients with severe disease began enrolling patients on February 6. The study in patients with moderate disease began enrolling patients on February 13. Clinical trial results are anticipated in April.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has 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. Gilead is providing study drug at no charge and has provided input on study design and conduct.

COMPASSIONATE USE

Gilead is working with government and non-government organizations and regulatory authorities to provide remdesivir to patients with COVID-19 for emergency treatment in the absence of any approved treatment options.

Compassionate use requests must be submitted by a patient’s treating physician. Gilead is currently assessing requests on an individual basis and requires, at a minimum, that the patient be hospitalized with confirmed COVID-19 infection with significant clinical manifestations.
It is important to note that results in individual compassionate use cases are not sufficient to determine the safety and efficacy of remdesivir in treating COVID-19 – this can only be determined through prospective clinical trials.

INCREASING MANUFACTURING CAPACITY AND SUPPLY

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 doing this before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID-19.

To increase available clinical supplies of remdesivir, Gilead is also 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. Gilead is actively collaborating with government agencies on COVID-19 response efforts, and is sharing regular updates with them on the company’s manufacturing scale-up.

ACCESS TO REMDESIVIR AND FUTURE STUDY

Gilead is mapping out options to make access to investigational remdesivir more widely available through appropriate channels for emergency use should it demonstrate the potential to be a safe and effective treatment option based on the results of preliminary clinical trials.
Gilead is also in discussions with regulatory agencies to determine the most appropriate pathway for submitting remdesivir for approval for the treatment of COVID-19 in the event the trial results are positive.

Finally, Gilead is in discussion with multiple organizations regarding the potential for future trials.

MORE INFORMATION

Please contact Gilead via email with any questions (coronavirus.response@gilead.com).

[Gilead report] [Gilead Sciences]