In order to expand the potential uses of the drug against SARS-CoV-2, Gilead Sciences has announced plans to explore administration of remdesivir in an inhaled form. The decision was explained in an open letter from the company’s CEO, Daniel O’Day.
Delivering the antiviral via a nebulizer would allow for early administration, according to O’Day, which would fit data that suggest earlier use is more beneficial. The US Food and Drug Administration (FDA) has given Gilead the go-ahead to initiate clinical trials.
“After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version of remdesivir. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August,” O’Day wrote. “An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease. That could have significant implications in helping to stem the tide of the pandemic.”
Early last month, remdesivir was granted Emergency Use Authorization
by the FDA. The authorization was based on several studies which were detailed in late April.
In the National Institutes of Allergy and Infectious Diseases (NIAID) “SIMPLE” study, remdesivir shortened recovery time by an average of 4 days for moderately ill patients (defined as those in hospital but not requiring oxygen). Study participants on a five-day course of remdesivir had superior clinical outcomes to those receiving standard of care. Treatment was shown most beneficial in patients who did not yet require medical ventilation, supporting study in patients with earlier disease progression or who are still not hospitalized.
“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,” O’Day explained.
To elaborate on combination therapies, O’Day articulated the dynamics some suspect define severe coronavirus disease 2019 (COVID-19)
illness. At first, the virus itself appears to drive illness. This is why an anti-viral like remdesivir or favipiravir
might work best against SARS-CoV-2 early on.
On the other hand, the late-stage of disease progression appears to be driven by the body’s own inflammatory response.
“Over the coming months we will see results from studies of remdesivir with 2 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,” O’Day wrote. “Last week’s news on dexamethasone appears to further support the study of complementary approaches for treating COVID-19. Dexamethasone is a steroid that potentially reduces the body’s inflammatory response to the virus.”
The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial
, a UK-based, randomized trial with 2104 patients receiving dexamethasone 6 mg once daily for 10 days, compared the therapy to another 4321 patients also randomized to usual care.
Dexamethasone appeared to reduce deaths by one-third in ventilated patients, and by one-fifth in patients receiving oxygen. Earlier evidence
from the SARS-1 outbreak suggested corticosteroids may not be beneficial in COVID-19 treatment, and this earlier information has yet to be reconciled in order to deliver a definitive answer.
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