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Even as Indian drugmakers roll out their versions of anti-viral remdesivir, Gilead Sciences said it will start clinical trials on an inhaled version of remdesivir, having received the green signal from the Food and Drug Administration.
In an open letter, Gilead Chairman and Chief Executive Daniel O’Day, said: “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, he said, this could represent important progress. “Remdesivir, our investigational anti-viral medicine, is currently given to patients intravenously through daily infusions in the hospital. An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at the earlier stages of the disease. That could have significant implications in helping stem the tide of the pandemic.”
The US-based biopharmaceutical chief further said: “We have already learned a lot about how remdesivir works in a relatively short space of time. All of us at Gilead are grateful for the strong collaborations that helped make this possible and to the thousands of patients who have taken part in clinical trials.”
Remdesivir is now being used to treat patients through emergency use authorisations and other access programmes around the world. “And yet, we still have some way to go in exploring the full potential of remdesivir to help fight Covid-19,” he said.
“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.”
So far, randomised controlled trials of remdesivir have been evaluating its safety and efficacy in hospitalised patients. In the NIAID study, remdesivir shortened recovery time by an average of four days, and in the SIMPLE study of moderately ill patients (those in hospital but not requiring oxygen), individuals on a five-day course of remdesivir had better clinical outcomes than those receiving standard of care, he said.
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