Atea to lead global clinical trial development of AT-527 and regain ex-US commercial rights

BOSTON, MA, USA I November 16, 2021 I Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that the strategic collaboration pursuant to which it was jointly developing AT-527 for the treatment of COVID-19 with Roche will be terminating. Upon termination, the rights and licenses granted by Atea to Roche under the strategic collaboration will be returned to Atea, and Atea will have full rights to continue the clinical development and future commercialization of AT-527 worldwide.

“We believe strongly in the potential of AT-527 with its unique dual mechanism of action, antiviral activity against the major variants of concern and its market potential given the need for additional therapeutic options for COVID-19,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “We have the financial resources and the talent to independently drive forward the Phase 3 MORNINGSKY clinical trial program, and we continue to expect data from this trial during the second half of 2022. We are energized by the opportunity to move forward with full ownership, providing us with autonomy to efficiently bring AT-527 to market.”

The strategic collaboration with Roche, which included joint development, will be terminated on February 10, 2022.

“We are continuing to expedite efforts to submit the recently announced Phase 3 MORNINGSKY amendment to global health authorities,” said Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals. “We have an established development team at Atea with extensive global clinical trial experience, as well as outside resources we continue to leverage. We remain committed to developing and delivering AT-527 as an oral antiviral that will address treatment needs for patients as COVID-19 continues to evolve.”

As of September 30, 2021, Atea reported cash and cash equivalents of $839.7 million with a cash runway through 2023.

About the AT-527 COVID-19 Clinical Development Program

Derived from Atea’s nucleos(t)ide prodrug platform, AT-527 is an oral direct-acting antiviral which is being studied to determine its potential to protect against disease progression and the development of long-COVID complications. Its unique mechanism of action, with dual targets including chain termination (RdRp) and NiRAN inhibition, has the potential to create a high barrier to resistance with broad antiviral coverage to different variants of SARS-CoV-2. Atea has completed a comprehensive nonclinical program to characterize the safety profile of AT-527. Results observed from these nonclinical studies demonstrated that AT-527 was non-mutagenic, had no effects on fertility or reproduction and was non-teratogenic.

Atea is evaluating AT-527 across multiple clinical trials that are advancing in parallel, including the global Phase 3 MORNINGSKY trial.

About Atea Pharmaceuticals

Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, 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

SOURCE: Atea Pharmaceuticals