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September 23, 2021

Gilead’s Veklury reduces hospitalisation risk in Phase III Covid-19 trial

By day 28, subjects receiving Velkury had an 81% reduction in risk of medical visits due to Covid-19 or all-cause death.

Gilead Sciences has reported positive data from a Phase III clinical trial of Veklury (remdesivir) to treat Covid-19 in non-hospitalised patients who are at increased risk of disease progression.

A nucleotide analogue discovered by Gilead, Veklury is the antiviral standard of care to treat hospitalised Covid-19 patients.

It directly hinders the viral replication of the SARS-CoV-2 virus by acting on the viral ribonucleic acid (RNA) polymerase inside of the cell.

The randomised, double-blind, placebo-controlled Phase III Study GS-US-540-9012 (PINETREE) assessed the efficacy and safety of a three-day regimen of intravenous (IV) Veklury.

It was designed to enrol 1,264 subjects to receive either Veklury or a matching placebo.

Earlier this year, Gilead suspended the trial due to the evolution of the Covid-19 landscape and changing patient requirements, thereby enrolling 584 subjects.

The composite of Covid-19 hospitalisation or all-cause mortality by day 28 was the trial’s primary goal.

Secondary outcome measures included the composite endpoint of medical visits due to Covid-19 or all-cause mortality by day 28.

According to the analysis of 562 subjects, Veklury offered a statistically significant 87% decline in risk for the composite primary goal versus placebo.

Furthermore, subjects in the Velkury arm had an 81% reduction in risk of medical visits due to Covid-19 or all-cause mortality by day 28 versus the placebo group.

No deaths were reported in either of the trial groups by day 28, findings showed.

Gilead Sciences chief medical officer Merdad Parsey said: “As the pandemic continues to evolve and new viral variants emerge, Veklury is playing a critical role as the antiviral standard of care for hospitalised patients, helping prevent disease progression and speed patients’ recovery.

“As leaders in antiviral drug development, we welcome these findings and continue to invest in research of Veklury and novel oral antivirals to address the unmet need for effective and convenient therapies that can be administered at home.”

The company reported in June 2021 that real-world data from three retrospective studies showed Veklury decreased the risk of mortality in hospitalised Covid-19 patients.

In another development, Clover Biopharmaceuticals has reported that its adjuvanted protein-based Covid-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) met the primary efficacy and secondary efficacy goals in the Phase II/III SPECTRA trial.

The vaccine showed an overall efficacy of 79% against Covid-19 of any severity caused by the Delta variant.

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