In an open letter, Daniel O’Day, Chairman & CEO, Gilead Sciences divulged that Gilead is about to start trials of an inhaled version of remdesivir. The company has received a go-ahead from the US FDA to move forward with the trial.
O’Day stated, “We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August. If the trials are successful, this could represent important progress.”
“An inhaled formulation would be given through a nebuliser, which could potentially allow for easier administration outside the hospital, at earlier stages of the disease. That could have significant implications in helping to stem the tide of the pandemic,” said the CEO, through the letter.
He disclosed, “As part of our next wave of clinical development, we will study remdesivir in treating earlier in the disease, in combination with other therapies and in additional patient groups. The inhaled formulation studies are one means of exploring the use of remdesivir in the earlier stages of COVID-19. We will also conduct trials using intravenous infusions in outpatient settings such as infusion centres and nursing homes. For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital. Our hope is that earlier intervention could help patients avoid hospitalisation altogether.
Informing that Gilead Sciences is exploring patient outcomes can be improved by combining remdesivir with other therapies, he stated, “We have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients. Over the coming months, we will see results from studies of remdesivir with two immune modulators. One study is looking at remdesivir with the JAK inhibitor, baricitinib, and a second is studying remdesivir in combination with the IL-6 receptor antagonist tocilizumab.”
Adding that the company is extending its focus to earlier treatment and combinations, Gilead’s CEO informed, “our next wave of studies of remdesivir will include vulnerable patient populations.” The study will treat approximately 50 children, from newborns to adolescents who are hospitalised with COVID-19. We are also collaborating with an external group on a study in pregnant women, and we are planning a trial for patients with end-stage renal disease.”
He asserted, “Gilead will do all it can to help drive that progress by exploring the full potential of remdesivir.”