Data Suggest AT-527 May Improve Treatment of Patients with COVID-19, Hepatitis C

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Atea’s drug candidate is considered safe and effective against the viruses that cause COVID-19 and hepatitis C, according to new data presented at ICAR 2023.

Atea Pharmaceuticals, Inc. presented phase 1 in vitro and in vivo data on AT-527 (bemnifosbuvir, an investigational, oral, direct-acting antiviral for the treatment for COVID-19 and hepatitis C virus (HCV), at the 36th International Conference on Antiviral Research (ICAR 2023) in Lyon, France, held March 13 to 17, 2023.1

“As COVID-19 becomes endemic, it is essential to have new oral antiviral medicines that are safe, well tolerated and address the current limitations of existing treatments,” said Bruno Canard, PhD, lead investigator of AT-527 ‘s in vitro studies conducted at Architecture et Fonction des Macromolécules Biologiques, CNRS and Aix-Marseille University, in a press release.1

Investigators evaluated dosing for AT-527 in a phase 1 human absorption, distribution, metabolism, and excretion (ADME) study, in which it showed a favorable profile. They used this dose in the phase 3 SUNRISE-3 trial, which is evaluating AT-527 as treatment for COVID-19 in non-hospitalized patients at increased risk of disease progression. Investigators are also conducting a phase 2 trial to evaluate AT-527 as a combination treatment with ruzasvir (oral NS5A inhibitor) for HCV.1

The early in vitro metabolism and transporter interaction studies suggest that AT-527 does not pose a great risk of interacting with common medications for COVID-19 or HCV infection.1

“These data support a favorable safety and drug interaction profile of AT-527 to treat these conditions and to provide vulnerable patients with another therapeutic option,” said Jean-Pierre Sommadossi, PhD, chief executive officer and founder of Atea Pharmaceuticals, in the press release.1

AT-527 was also found to increase resistance against COVID-19 and its variants while sustaining antiviral activity. Regarding HCV, investigators observed that AT-527 with ruzasvir had synergistic antiviral activity, with a preclinical in vivo analysis demonstrating it to be safe.1

“Data presented at ICAR [also] demonstrate AT-527’s unique metabolic activation pathway,” Canard added in the press release. This function allows AT-527 to inhibit enzymes that facilitate the viral replication of COVID-19 and HCV and is advantageous to defending against infection,” Canard explained in the press release.1

SUNRISE-3 is a randomized, double-blind, placebo-controlled, global phase 3 trial evaluating AT-527 or placebo with standard of care non-hospitalized patients with mild or moderate COVID-19. The primary endpoint is all-cause hospitalization or death in patients on monotherapy AT-527.2

Atea also presented data about AT-752 for dengue and a nucleotide analogue at ICAR 2023.1

“As we continue to advance late-stage development of AT-527, these data demonstrate that our lead compound has the potential to improve the current standard of care and address key unmet needs and limitations for patients with COVID-19 and HCV,” Sommadossi said in the press release.1

References

  1. Atea Pharmaceuticals. New Data Showcasing Favorable Profile of Bemnifosbuvir for Treatment of COVID-19 and Hepatitis C Presented at 2023 International Conference on Antiviral Research. News Release. March 14, 2023. Accessed March 15, 2023. https://www.biospace.com/article/releases/new-data-showcasing-favorable-profile-of-bemnifosbuvir-for-treatment-of-covid-19-and-hepatitis-c-presented-at-2023-international-conference-on-antiviral-research/
  2. Atea Pharmaceuticals. Seeking to combat COVID-19 with an oral RNA viral polymerase inhibitor. Article. Accessed March 15, 2023. https://ateapharma.com/covid-19/bemnifosbuvir/
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