Gilead Initiates Phase 1a Clinical Trial of Inhaled Remdesivir for Outpatient Treatment of COVID-19

On July 8, 2020 (U.S. time), Merdad Parsey, M.D., Global Chief Medical Officer of Gilead Sciences, issued the following statement on behalf of the company:

“Since the onset of the COVID-19 pandemic, Gilead has leveraged its deep expertise in virology to rapidly evaluate remdesivir, its potent investigational antiviral drug, to determine its safety and efficacy as a potential treatment option for patients with COVID-19. As promising data have emerged from randomized clinical trials of intravenous remdesivir in hospitalized patients, the need to investigate the drug’s potential for use in the outpatient setting has become clear. Extensive research efforts on an inhaled spray formulation of remdesivir are already underway. We are pleased to announce the initiation of a Phase 1a clinical study of the investigational inhaled formulation of remdesivir to assess its safety, tolerability, and pharmacokinetics in healthy volunteers.”

Based on current scientific understanding, the upper respiratory tract is the most common site of viral infection in the early stages of novel coronavirus pneumonia. Directly delivering remdesivir to the primary site of infection via nebulized inhalation can make medication administration more targeted and accessible for non-hospitalized patients, while potentially reducing systemic exposure to the drug in the body. This randomized, placebo-controlled trial will recruit approximately 60 healthy individuals aged 18–45 years in the United States, serving as a foundation for further clinical research on inhaled medications, particularly for patients whose condition has not yet progressed to requiring hospitalization.

Research into an inhaled solution of remdesivir is a key focus of our ongoing work, aimed at enhancing the therapeutic efficacy of remdesivir for patients and expanding access to this treatment. Additional clinical trials targeting susceptible patient populations, outpatient administration, and combination therapies with anti-inflammatory agents are currently underway or planned for imminent launch. We will continue to share new data with regulatory authorities, the scientific community, and the medical community, fostering multi-stakeholder collaboration to help meet the needs of patients worldwide.

About Remdesivir

Remdesivir is a nucleotide analog that exhibits broad-spectrum antiviral activity both in vivo and in vitro, acting against various emerging viral pathogens. Multiple ongoing global Phase III clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of coronavirus disease 2019 (COVID-19). The approval status of remdesivir varies by country. In countries where it has not been approved by local health authorities, remdesivir remains an investigational drug, and its safety and efficacy have not been established.

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