Gilead Sciences (NASDAQ: GILD) 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.”