Atea Pharmaceuticals Announces First Patient Dosed in Phase 2 Virology Trial of AT-527 in Outpatient Setting

Rhea-AI Summary

Atea Pharmaceuticals (Nasdaq: AVIR) has commenced a Phase 2 clinical trial for AT-527, an oral antiviral treatment for patients with mild to moderate COVID-19. The trial, conducted in collaboration with Roche, aims to evaluate the drug's virological efficacy, safety, and pharmacokinetics, enrolling up to 220 patients across the UK, Ireland, and other countries. Primary outcomes will measure changes in SARS-CoV-2 virus RNA levels. AT-527 has shown promise in inhibiting viral replication in vitro, and the study aims to support the development of effective outpatient treatment options.

Positive

• First patient dosed in Phase 2 trial for AT-527 targeting mild to moderate COVID-19.
• Collaboration with Roche enhances credibility and potential for successful outcomes.
• AT-527 has demonstrated in vitro efficacy against SARS-CoV-2 viral replication.

Negative

• None.

Trial to evaluate the virological efficacy of AT-527 on SARS-CoV-2 in patients with mild to moderate COVID-19

BOSTON, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 2 virology trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial will enroll patients in the United Kingdom (UK), Ireland and other countries. AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea’s purine nucleotide prodrug platform.

“In collaboration with Roche, we are initiating a randomized virology study in the UK and Ireland, where COVID-19 is fast-spreading and an estimated 30-40% of new infections involve a new mutation. This study presents the opportunity to investigate the antiviral activity of AT-527 in these patients. Importantly, this study is evaluating patients in an outpatient setting, which is the anticipated patient population of the upcoming Phase 3 trial,” said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. “While vaccines will play an important role in controlling the COVID-19 pandemic, we need additional treatment options to stay ahead of the virus, and direct-acting antivirals have the potential to be an essential complement to vaccines.”

AT-527 has been shown to inhibit viral replication of SARS-CoV-2 in vitro. The ultimate goal is to effectively address the ongoing need for a safe and effective oral antiviral that is suitable for easy and early administration to reduce the severity of the disease, thereby reducing the burden on the global healthcare system.

The randomized, double-blind, placebo-controlled Phase 2 trial will evaluate the antiviral activity, safety, and pharmacokinetics of AT-527 550 mg twice-daily in adult patients with mild or moderate COVID-19 in an outpatient setting. There will be multiple cohorts included in the trial investigating potentially alternative dosing regimens in addition to the 550 mg twice-daily dosing. The study will enroll up to 220 patients in the UK, Ireland and other countries.

The primary endpoint of this trial is change from baseline in amount of SARS-CoV-2 virus RNA as measured by reverse transcription polymerase chain reaction (RT-PCR) at specified timepoints.

“We look forward to rapid enrollment of this important study and hope it will provide further evidence of AT-527’s antiviral activity against SARS-CoV-2. Our goal is to provide as soon as possible an easily administered and widely accessible treatment to fight this global pandemic and to treat and curtail its spread worldwide,” said Janet Hammond, MD, Ph.D., Chief Development Officer of Atea Pharmaceuticals.

About AT-527

AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea’s nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study. A pivotal Phase 3 trial is planned in the outpatient setting.

About Atea Pharmaceuticals

Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing, and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the company’s deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

Contacts

Investors:

Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
Barnes.jonae@ateapharma.com

Will O’Connor
Stern Investor Relations
212-362-1200
will.oconnor@sternir.com

Media:
Carol Guaccero
301-606-4722
contactus@ateapharma.com

FAQ

What is the purpose of the AT-527 trial conducted by Atea Pharmaceuticals?

The trial aims to evaluate the virological efficacy, safety, and pharmacokinetics of AT-527 in patients with mild to moderate COVID-19.

When was the first patient dosed in the AT-527 trial?

The first patient was dosed on February 4, 2021.

How many patients will be enrolled in the AT-527 trial?

The trial will enroll up to 220 patients.

What countries are involved in the AT-527 trial?

The trial is being conducted in the UK, Ireland, and other countries.

What are the primary endpoints of the AT-527 trial?

The primary endpoint is the change from baseline in the amount of SARS-CoV-2 virus RNA, measured by RT-PCR at specified timepoints.