Gilead Begins Testing Inhaled Version of Remdesivir for Treatment of COVID-19
By HospiMedica International staff writers Posted on 10 Jul 2020 |
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Gilead Sciences, Inc. (Foster City, CA, USA) has initiated clinical testing of an inhaled solution of remdesivir for potential outpatient treatment of COVID-19.
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. With promising data emerging from the randomized, clinical trials of intravenous remdesivir administered to hospitalized patients, the company is making efforts to investigate the drug’s potential in the outpatient setting.
Gilead has made significant research efforts to deliver remdesivir in an inhaled, nebulized format. 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.
Gilead has now initiated a Phase 1a clinical study to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers. The randomized, placebo-controlled trial will enroll approximately 60 healthy individuals aged 18-45 in the US 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,” said Gilead in a company statement. “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.”
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Gilead Sciences, Inc.
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. With promising data emerging from the randomized, clinical trials of intravenous remdesivir administered to hospitalized patients, the company is making efforts to investigate the drug’s potential in the outpatient setting.
Gilead has made significant research efforts to deliver remdesivir in an inhaled, nebulized format. 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.
Gilead has now initiated a Phase 1a clinical study to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers. The randomized, placebo-controlled trial will enroll approximately 60 healthy individuals aged 18-45 in the US 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,” said Gilead in a company statement. “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.”
Related Links:
Gilead Sciences, Inc.
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