Infectious disease biotech and Fierce 15 winner Atea Pharmaceuticals alongside partner Roche have shown their antiviral can cut the viral load of SARS-CoV-02 in ill patients, though more data from a bigger trial will be needed to fully detail the level of success.
In an interim analysis of a phase 2 trial, Atea and Roche said their oral direct-acting antiviral, known as AT-527, helped cut viral load across 62 hospitalized patients with moderate COVID-19. “Interim virology results indicated that AT-527 rapidly reduced viral load levels,” the pair said in a statement.
Data are still sparse, and more are yet to be published—and it’s only via a press release—but the early peek showed that on the second day of taking the med, patients saw an 80% greater mean reduction from baseline viral load as compared to placebo.
A sustained difference in viral load reduction was maintained through Day 8, while after two weeks, the last viral sampling study day, just under half (47%) of patients in the AT-527 arm and 22% in the placebo arm had no detectable RNA virus. Atea and Roche said there were “no safety concerns.”
The test was designed to include those with known COVID risk factors such as obesity, diabetes and hypertension. A detailed breakdown will be published at an upcoming meeting.
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There were no data about actual efficacy in terms of reducing illness severity or death, though this trial was not powered for that. Instead, the study was designed to see whether the drug was safe and tolerable, while also noting the viral reduction—which was a plus.
The real data will be from a late-stage test, known as the MORNINGSKY trial, which is assessing clinical outcomes and will be powered to show if the med works. Data from this are expected in the coming months and will be the make-or-break test.
“We are very pleased with the potent antiviral activity of AT-527 demonstrated by the rapid inhibition of SARS-CoV-2 replication. Such potent activity may lead to faster recovery time for patients with COVID-19 while minimizing the transmission of infection,” said Jean-Pierre Sommadossi, Ph.D., CEO and founder of Atea Pharmaceuticals. “As COVID-19 continues to evolve worldwide, we need a multi-pronged approach to control this disease.”
Atea’s quarry is a key viral enzyme known as RNA polymerase, a necessary component that allows the pathogen to copy itself, survive and spread. It’s a target shared with Gilead’s remdesivir, which last year was the first drug to nab an emergency green light from the FDA against COVID-19.
Atea was launched back in 2014 by Sommadossi—former co-founder of Pharmasset, developer of the hepatitis C drug Sovaldi. Since then, the company has amassed a library of more than 1,000 proprietary prodrugs aimed at various viral RNA polymerases. Last year, the company drafted AT-527 from that library, and it's one of the latest new hopes against COVID-19.
And Atea is not doing it alone: Last year, the company grabbed a $350 million deal with Swiss major Roche, which nabbed ex-U.S. rights to the drug, coming after raising $215 million last March at the start of the first wave of COVID.
Atea retains responsibility for distributing the drug in the U.S., although it has an option to ask for the support of Roche’s biotech arm Genentech if need be. Though a small biotech, it has some major backing for these efforts.
Roche foresees AT-527 being used to treat patients early, perhaps even in post-exposure prophylactic settings.
Both companies will hope to have better luck than rival Merck, which has been beset by COVID drug (and indeed vaccine) woes, with antiviral hopefuls from other biotechs also failing to live up to the success we have seen with shots.
With vaccine rollout in some countries going well, there are questions as to whether we need COVID drugs. Due to the explosion of the new and more transmissible delta variant, which will likely be the dominant strain before year-end globally—and its capacity to evade some vaccine immunity (and the fact that most of the world still isn’t anywhere near herd immunity)—demand for antivirals will likely remain high for some time.
An oral version, and not one that needs to be infused, like the antibody drugs from Eli Lilly and Regeneron (both of which are also susceptible to variants), will also be a more attractive option.
Atea was up 7% premarket Wednesday morning on the news.