Gilead Sciences Statement on the Initiation of Clinical Testing of an Inhaled Solution of Remdesivir for Potential Outpatient Treatment of COVID-19
Foster City, Calif., July 8, 2020 – Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences:
“Since the beginning of the COVID-19 pandemic, Gilead has mobilized its deep expertise in virology to rapidly assess the potent investigational antiviral, remdesivir, to evaluate its safety and efficacy as a potential treatment option for patients with COVID-19. With promising data emerging from the randomized, clinical trials of intravenous remdesivir administered to hospitalized patients, it became clear that efforts were needed to investigate the drug’s potential in the outpatient setting. Significant research efforts have been undertaken to deliver remdesivir in an inhaled, nebulized format. We are pleased to announce the initiation of a Phase 1a clinical study to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers.
Based on current scientific understanding, the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in disease. Delivering remdesivir directly to the primary site of infection with a nebulized, inhaled solution may enable more targeted and accessible administration in non-hospitalized patients and potentially lower systemic exposure to the drug. This randomized, placebo-controlled trial will enroll approximately 60 healthy individuals aged 18-45 in the United States to form the basis for further clinical study of the inhaled drug, particularly in patients whose disease has not progressed to require hospitalization.
Research on this inhaled solution of remdesivir represents an important pillar of our ongoing work that aims to potentially enhance patient outcomes with remdesivir and enable more patients to access this treatment. Additional clinical trials evaluating remdesivir in combination with anti-inflammatory medicines, in vulnerable patient populations and in outpatient settings are ongoing or planned to initiate in the near future. We will continue to share emerging data with regulatory authorities and the scientific and medical community as we work together to help address the needs of patients around the world.”
Remdesivir is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2, the virus that causes COVID-19. The approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir has not been established. In the U.S., the U.S. Food and Drug Administration (FDA) granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19; this authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the U.S., please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available at www.16xinbu.icu/remdesivir.
This statement includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational agent that has not been approved by the FDA for any use, and it has not been demonstrated to be safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory agencies may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.