AVIR Atea Pharmaceuticals initiates first-in-human phase 1 clinical trial of at-587 for the treatment of hepatitis e virus

Atea Pharmaceuticals, Inc. (NASDAQ: AVIR ) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the initiation of a first-in-human Phase 1 clinical trial evaluating AT-587, for the treatment of hepatitis E virus (HEV) infection. AT-587 is a proprietary oral antiviral nucleotide analog being developed for the treatment of HEV, a potentially serious liver disease that can lead to chronic infection, cirrhosis and liver failure in certain patient populations. In particular, at-risk populations include immunocompromised individuals, such as transplant recipients and patients taking immunosuppressants, among others. There are currently no approved treatments for HEV. "HEV is a significant health concern, particularly among immunocompromised patients who are at heightened risk for chronic infection and rapidly progressive liver disease, and the initiation of our Phase 1 trial represents an opportunity to address a substantial unmet need," said Jean-Pierre Sommadossi, PhD, founder and chief executive officer of Atea Pharmaceuticals. "Supported by encouraging preclinical data demonstrating potent antiviral activity, we believe AT-587 has the potential to become an important therapeutic option for patients, particularly transplant recipients and immunocompromised patients living with HEV. Advancing AT-587 into the clinic builds on our deep expertise in antiviral drug development and represents another step in expanding Atea’s viral hepatitis franchise." The Phase 1 trial is a randomized, double-blind, placebo-controlled, sequential dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy volunteers. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) components, as well as an embedded food-effect assessment. Part A of the study will evaluate single ascending doses of AT-587 administered under fasting conditions, with one cohort incorporating both fasting and fed administration to assess food effect. Part B of the study will evaluate multiple ascending doses of AT-587 administered once daily or twice daily for seven days, with dose selection informed by safety and PK data generated in Part A. Dose escalation decisions will be guided by ongoing review of emerging safety and PK data, providing flexibility to adapt the doses as clinical experience with AT-587 evolves.