Roche Gains Covid-19 Oral Drug Candidate

(stevepb, Pixabay)

22 Oct. 2020. Global drug maker Roche Group is acquiring an experimental antiviral therapy for Covid-19 infections taken as a oral drug, rather than an infusion. The deal provides Atea Pharmaceuticals Inc. in Boston, developer of the therapy code-named AT-527, $350 million in an initial payment, with more payments later as unspecified milestones are achieved.

Atea Pharmaceuticals develops antiviral prodrugs, precursor compounds that metabolize in the body to become active drug ingredients. The company says it has a library of some 1,000 prodrug candidates made of nucleic acid components that act against specific RNA polymerases, enzymes that help transcribe DNA to RNA and promote replication of the virus in the body. Atea says it refines these candidates into working therapies by enhancing their antiviral potency, selectivity, and tolerability as oral drugs.

The company says it’s advancing AT-527 as an oral drug to treat patients with Covid-19 infections. Atea first designed AT-527 as a treatment for hepatitis-C infections, where the company says early and mid-stage clinical trials demonstrate its safety. When its potential to treat coronavirus infections was discovered, Atea began testing AT-527 as a Covid-19 therapy. The company says its hepatitis-C studies show AT-527 is safe for patients for up to 12 weeks with a daily dose of 550 milligrams. The results also show the drug is absorbed quickly by patients and has a long shelf life.

Atea’s founder and CEO Jean-Pierre Sommadossi says in a statement, “AT-527 is expected to be ideally suited to combat Covid-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.”

AT-527 is now being tested in a mid-stage clinical trial with hospitalized patients having moderate Covid-19 infections. The 190 trial participants are older, age 45 to 80, and have additional risk factors such as obesity, hypertension, or diabetes. Participants are randomly assigned to receive one or two tablets of AT-527, each 550 milligrams, or a placebo, on the first day, followed by one tablet a day for another four days. The study team is looking primarily for changes in participants’ respiratory capacity and blood oxygen levels, as well as signs of adverse effects from the drug. Researchers are also tracking time needed for patients to recover, or if they encounter respiratory failure or death.

Roche plans to evaluate AT-527’s potential among non-hospitalized Covid-19 patients as well. “By joining forces with Atea,” says Roche Pharmaceuticals’ CEO Bill Anderson, “we hope to offer an additional treatment option for hospitalized and non-hospitalized Covid-19 patients, and to ease the burden on hospitals during a global pandemic.” A late-stage trial is planned for the first quarter of 2021 testing AT-527 among non-hospitalized Covid-19 patients.

The agreement calls for Atea and Roche to collaborate on clinical trials and manufacturing of AT-527. Atea will be responsible for distribution of AT-527 in the U.S., although it has the option to call on Roche’s Genentech subsidiary if needed. Roche is responsible for distribution outside the U.S.

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