Atea Pharmaceuticals to Present Bemnifosbuvir and Ruzasvir Data for the Treatment of Hepatitis C Virus at AASLD The Liver Meeting 2023
BOSTON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced two upcoming poster presentations at The Liver Meeting 2023, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place from November 10-14, 2023 in Boston, MA.
"We are very pleased to share with the scientific and clinical community supportive data for bemnifosbuvir and ruzasvir, highlighting the potential to use these two compounds together as a novel treatment for hepatitis C virus (HCV)," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "We are encouraged by the highly potent, pan-genotypic antiviral activity of these compounds, along with the favorable drug-drug interaction and safety profile observed to-date, which supports their use in combination. Despite treatment options for HCV, there remains a large, underserved HCV patient population that continues to grow dramatically due to the opioid crisis, injection drug use and HCV reinfection."
Details for the presentations are as follows:
Poster Number: 1861-A
Title: Bemnifosbuvir and Ruzasvir are Potent HCV DAAs with Favorable Antiviral Profiles Against Major HCV NS5A and NS5B RAVs Supporting Use in Combination
Date and Time: Friday, November 10, 1:00 PM – 2:00 pm
Location: Hall A
Poster Number: 1879-A
Title: Lack of Pharmacokinetic Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir in Healthy Participants
Date and Time: Friday, November 10, 1:00 PM – 2:00 PM
Location: Hall A
About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV)
Atea is currently conducting a Phase 2 open-label study evaluating bemnifosbuvir in combination with ruzasvir (RZR) in treatment-naïve HCV-infected patients, either without cirrhosis and or with compensated cirrhosis. This study aims to assess the safety and efficacy of eight weeks of treatment with the pan-genotypic combination, consisting of once-daily bemnifosbuvir 550 mg and RZR 180 mg. Approximately 280 treatment-naïve HCV-infected patients are anticipated to be enrolled across all genotypes, including a 60 patient lead-in cohort.
Bemnifosbuvir, a nucleotide polymerase inhibitor, has been shown to be approximately 10-fold more active than sofosbuvir (SOF) in vitro against a panel of laboratory strains and clinical isolates of HCV genotypes 1–5. In vitro studies demonstrated bemnifosbuvir remained fully active against SOF resistance-associated strains (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV and bemnifosbuvir has been well-tolerated at doses up to 550 mg for durations up to 8-12 weeks in healthy and HCV-infected subjects.
RZR, an oral NS5A inhibitor, has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. RZR has been administered to over 1,200 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. RZR’s PK profile supports once-daily dosing.
About Atea Pharmaceuticals
Atea is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging the Company’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Currently, Atea is focused on the development of orally-available antiviral agents for serious viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and hepatitis C virus (HCV). For more information, please visit .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the dates and times of the poster presentations, our expectations surrounding the potential of our product candidates, including bemnifosbuvir combination product candidates generally and in particular the combination of bemnifosbuvir and RZR, and expectations regarding our pipeline, including trial design and development timelines. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the uncertainty around and costs associated with the clinical development of the combination of bemnifosbuvir and RZR as a potential treatment for HCV and bemnifosbuvir as a potential treatment for COVID-19. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
Contacts
Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
Will O’Connor
Stern Investor Relations
212-362-1200
