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Gilead will test inhaled remdesivir in earlier-stage COVID-19

Phase 1 trial due to start in August

Gilead

Gilead Sciences plans to start testing an inhaled formulation of its lead COVID-19 therapy remdesivir – currently dosed intravenously – that could allow it to be given to earlier-stage patients outside hospital.

In an open letter, Gilead’s chief executive Daniel O’Day said the new formulation of the drug – given via a nebuliser – will be given to healthy volunteers in a phase 1 trial due to start in August.

If it works, the inhaled version of the antiviral “could have significant implications in helping to stem the tide of the pandemic”, according to O’Day.

Remdesivir was the first drug to be shown to have an effect on COVID-19 in controlled clinical trials, and is currently the only drug with emergency use authorisation to treat COVID-19 in the US after the FDA pulled approval for chloroquine and hydroxychloroquine last week.

Gilead’s drug has shown that it can reduce the time spent in hospital for patients hospitalised with severe COVID-19 symptoms – down to 11 days from around 15 in a trial run by the National Institute of Allergy and Infectious Disease (NIAID) – although it hasn’t been proven to improve the chances of surviving the disease.

So far, the only drug that has reduced mortality in COVID-19 is dexamethasone, a low-cost generic steroid that cut the death rate for the most seriously-ill patients by 41% at 28 days in the large-scale RECOVERY trial.

That result has stolen some of remdesivir’s thunder as the lead drug candidate treating coronavirus infections, but there’s already talk of combining the drugs to improve outcomes further. Gilead meanwhile says that it needs to do a lot more testing of its antiviral therapy.

“We have already learned a lot about how remdesivir works in a relatively short space of time,” wrote O’Day in the letter, adding: “And yet, we still have some way to go in exploring the full potential of remdesivir to help against COVID-19.”

Combination studies and testing in additional patient groups are at the planning stages, said the CEO, noting that trials of remdesivir with anti-inflammatory drugs – Eli Lilly’s JAK inhibitor Olumiant (baricitinib) and Roche’s IL-6 blocker Actemra (tocilizumab) – will generate results in the coming months.

There was no news of a combination trial with dexamethasone, although O’Day said the RECOVERY data “appears to further support the study of complementary approaches for treating COVID-19”.

Last week, Gilead also announced it would start a trial of its antiviral drug remdesivir in children with COVID-19, in the wake of reports that some young people infected with the virus go on to develop serious and life-threatening inflammatory reactions. Additional studies will involve pregnant women and people with end-stage renal disease.

It is also planning to test the intravenous formulation of the drug outside hospital settings – in infusion centres and nursing homes, for example – to see if starting treatment earlier in patients at high risk of disease progression promotes better outcomes.

Article by
Phil Taylor

23rd June 2020

From: Research

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