Atea Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company, today announced an updated strategy for AT-527 to address the rapidly evolving SARS-CoV-2 and emerging variants by maximizing the compound’s unique profile for potential use as both a monotherapy and in combination. Taking into account the changing COVID-19 landscape with the anticipated availability of new antiviral treatment regimens, the global Phase 3 MORNINGSKY trial will be closed out and the ongoing Phase 2 hospitalized trial will be further amended to expand enrollment to unvaccinated, high-risk outpatients. Atea expects to provide a more detailed update on its strategy and new development plan in 2022.
“We believe strongly in AT-527’s potential to combat the evolving SARS-CoV-2 and emerging variants as a monotherapy and as an important backbone in potential combination therapy,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “Our new strategy enables us to rapidly drive forward a plan to maximize AT-527’s unique profile with a development approach designed to meet the current and future needs of COVID-19, which may include the emergence of new variants and drug resistance to other therapies.”
“The nucleoside class has been the cornerstone of effective oral antiviral combination treatments for severe viral diseases, and we are preparing for a future where combination regimens may be needed to treat COVID-19 as the virus and pandemic evolve. Importantly, we have the financial and internal resources to execute this strategy through key clinical and regulatory inflection points,” added Dr. Sommadossi.
“After careful consideration of the rapid evolution of SARS-CoV-2 and the emergence of variants combined with the increasing availability of new COVID-19 treatment options, including the anticipated new antiviral regimens, continuing the MORNINGSKY trial is not the most effective path forward,” said Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals. “Our new development plan will leverage AT-527’s unique profile with the objective to advance an oral, best-in-class, drug candidate that can be used broadly for the treatment of coronaviruses and for future pandemic preparedness.”
Atea will continue to advance the global AT-527 Phase 2 trial evaluating the safety, tolerability and virological activity of AT-527 in unvaccinated patients with risk factors with moderate COVID-19. This ongoing study is currently exploring doses up to 1,100 mg BID in patients who are managed in a hospitalized or confined setting. Atea intends to further amend this study to remove the requirement for patient confinement or hospitalization. The amended Phase 2 trial is expected to enroll up to 200 patients. Atea anticipates reporting data from this trial during 2022. In addition, Atea is initiating preclinical in vitro combination studies of AT-527 and other compounds with different mechanisms of action to evaluate additive and synergistic benefits.
In addition to MORNINGSKY, the follow-on MEADOWSPRING trial will also be closed out. The strategic collaboration with Roche will be terminated on February 10, 2022.