- Roche will pay $350 million in cash for partial rights to an oral antiviral drug that the Boston biotech Atea Pharmaceuticals has been developing to treat COVID-19.
- The antiviral, known as AT-527, is currently being tested in a Phase 2 study in hospitalized patients with moderate COVID-19. But a planned Phase 3 trial next year may explore the use of AT-527 outside of the hospital setting, and a second pivotal study will evaluate whether the drug can prevent COVID-19 in patients who have been recently exposed to the coronavirus as well.
- Though vaccines and engineered antibodies are closer to market, potent antivirals could also be particularly helpful in lowering the overall burden of the disease. Merck, Pfizer and now Roche are each developing such medicines, which aim to improve on Gilead's Veklury, one of the only drugs so far that regulators have cleared for use against COVID-19.
In the early days of the pandemic, when drugmakers and researchers began a worldwide scramble to repurpose existing drugs to treat people with COVID-19, the antiviral remdesivir, tested against Ebola, emerged as the first successful example.
But the drug, now known as Veklury, has significant limitations. Its benefits — chiefly an apparent ability to shorten hospital stays for very sick COVID-19 patients — are modest, and were recently called into question by negative results in a large study sponsored by the World Health Organization. The drug is complex and time-consuming to manufacture. And it's given intravenously over multiple days, limiting its potential to be used more broadly.
An oral antiviral, or an infusible drug specifically engineered to stop SARS-CoV-2 from replicating, could solve many of these problems. A pill, for example, is much easier to manufacture and distribute widely. It would also be less burdensome to administer earlier in a patient's disease course, when stopping the virus from spreading might help prevent the progression of COVID-19. And a drug tailor-made for COVID-19 should be more potent than a treatment originally designed for something else.
As time has gone on, multiple drugmakers have brought these types of candidates into human testing. Pfizer began a Phase 1 trial of a novel, intravenously administered antiviral in September. In preclinical tests, the drug showed potential against multiple coronaviruses, which could make it useful in future outbreaks. Merck has an antiviral pill in Phase 2 testing, with data expected shortly. The drug, licensed from biotech Ridgeback Therapeutics, has broad spectrum activity, expanding its future potential, Merck executives have said.
Now Roche is in the mix with AT-527, an experimental pill developed by Atea that interferes with the RNA of multiple viruses, among them SARS-CoV-2. Atea was cleared by the Food and Drug Administration in May to begin testing AT-527 in COVID-19, and raised $215 million from a wide group of investors to back the effort.
Roche will now accelerate that plan, and is envisioning a broad program ahead for the Atea drug, should it prove helpful to hospitalized patients. Positive results in the Phase 2 test could lead to a pivotal study in the first quarter of 2021 that will also include patients who aren't hospitalized. Another Phase 3 test in patients newly exposed to infection could follow.
Under the collaboration, Roche has acquired international rights to the drug and will help accelerate its development, and manufacture and distribute the antiviral overseas. Atea keeps remaining drug rights, though it can request Roche's help with U.S. distribution as well. Roche noted specifically in a statement that AT-527 can be manufactured "quickly and at scale."
The Swiss drugmaker recently cut a similar-type deal with Regeneron to help widely manufacture the biotech's experimental COVID-19 antibody drug, which could soon win an emergency clearance from U.S. regulators. It's also been testing its arthritis medicine Actemra against COVID-19, with mixed results.