Atea Pharmaceuticals to Present Bemnifosbuvir and Ruzasvir Data for the Treatment of Hepatitis C Virus at AASLD The Liver Meeting 2023
November 02 2023 - 7:00AM
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-ATitle: 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 pmLocation: Hall A
Poster
Number: 1879-ATitle: Lack of
Pharmacokinetic Drug-Drug Interaction Between Bemnifosbuvir and
Ruzasvir in Healthy Participants Date and
Time: Friday, November 10, 1:00 PM – 2:00
PMLocation: 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
www.ateapharma.com.
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 BarnesSVP, Investor Relations and Corporate
Communications617-818-2985Barnes.jonae@ateapharma.com
Will O’ConnorStern Investor Relations
212-362-1200will.oconnor@sternir.com
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