Gilead Sciences’ remdesivir is more likely to work in mild-to-moderate COVID-19 patients rather than severe cases, according to reporting from Reynald Castañeda, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company.
Castañeda explains: “Given its antiviral mechanism, interviewed experts noted that remdesivir has the potential to decrease viral load in less-severe patients. However, in those who are more critically ill, the disease’s inflammatory impact becomes the more significant factor to address.”
On 3 April, the European Medicines Agency (EMA) backed remdesivir for compassionate use for COVID-19 patients. One day later, Gilead noted that it had reduced remdesivir’s manufacturing timeline from one year to around six months. Remdisivir was also cleared by the FDA for emergency use on 20 March, but new applications were suspended as of 23 March after a flood of requests.
Castañeda adds: “There is both preclinical and human data showing remdesivir’s polymerase inhibitor mechanism can reduce viral load. However, interviewed experts cautioned that available data is still empirical in nature, and load reduction may not translate into clinically relevant outcomes like reducing hospital stay or decreasing mortality.”
While remdesivir is under investigation in multiple trials, data from two China-based, investigator-led, Phase III trials recruiting mild-to-moderate (NCT04252664) and severe (NCT04257656) patients are highly anticipated, as they could provide the first randomised data for the drug. Results are expected this month. Gilead’s own Phase III international trials in moderate (NCT04292730) and severe (NCT04292899) cases are expected to have data in May.
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