Gilead’s COVID-19 antiviral fails in Phase III
07 Feb 2024
Phase 3Clinical ResultFinancial Statement
Gilead disclosed during its fourth quarter earnings on Tuesday that oral antiviral obeldesivir missed its primary endpoint in the Phase III OAKTREE trial, which enrolled non-hospitalised patients with COVID-19 and no risk factors for severe disease.
Obeldesivir failed to improve time to symptom alleviation versus placebo, Gilead said, though it was well-tolerated.
The study failure comes just months after Gilead discontinued a separate Phase III trial of obeldesivir. In November, the drugmaker ended the BIRCH study in non-hospitalised patients at high risk for developing severe COVID-19, citing “lower-than-expected COVID-19 incidence rates and related hospitalisations or all-cause death by day 29." At the time, Gilead said the discontinuation was not due to safety or efficacy concerns.
It’s unclear whether Gilead is continuing development of the antiviral, which remains listed on the company’s pipeline online. According to ClinicalTrials.gov, the company has an ongoing study of obeldesivir in children and adolescents with COVID-19.
Long tailwind for Veklury
As for Gilead's existing COVID-19 treatment, Veklury, the company said fourth-quarter sales declined 28% to $720 million, although that was still roughly $200 million more than forecasts. Chief commercial officer Johanna Mercier expects Veklury will stick around, but be needed more on a seasonal basis. "Obviously, COVID-19 is here to stay… We believe there is a long tail to this one, unfortunately for patients," she said.
Meanwhile, quarterly sales of its biggest HIV treatment, Biktarvy, climbed 7% to $3.1 billion, missing projections by about $100 million.
All three of Gilead's cancer drugs experienced growth, with Trodelvy leading the pack with revenue soaring over 53% to $299 million, slightly below analyst forecasts of $305 million. Yescarta sales increased 9% to $368 million, while Tecartus surged to $98 million, up nearly 20% from the year-ago period.
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