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 three upcoming poster presentations
supporting the combination of bemnifosbuvir and ruzasvir as a
potential treatment for Hepatitis C Virus (HCV). The combination of
bemnifosbuvir, a nucleotide analog polymerase inhibitor, and
ruzasvir, an NS5A inhibitor, is in Phase 2 development for HCV.
These data will be presented at the American Association for the
Study of Liver Diseases’ (AASLD) The Liver Meeting 2024, being held
from November 15-19, 2024 in San Diego, CA.
“We look forward to presenting these important data, which
support the combination of bemnifosbuvir and ruzasvir and its
potential best-in-class profile for the treatment of HCV,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “The unrelenting high incidence rate of HCV
infections underscores the need for new therapies that can address
the unmet needs of today’s HCV patients, particularly those with
substance abuse disorders and comorbidities. We look forward to
reporting results from our Phase 2 study later this year and to
advancing this program into Phase 3 development.”
Details for the AASLD’s The Liver Meeting presentations are as
follows:
Poster Number: 1467Date and
Time: Friday, November 15, 1:00 p.m. – 2:00 p.m.
PTLocation: San Diego Convention
CenterTitle: Multiscale Modeling of Lead-in
Results from a Phase 2 Study of an 8-Week Combination Regimen of
Bemnifosbuvir and Ruzasvir in Patients with Chronic Hepatitis C
Virus InfectionPresenter: Ruy M. Ribeiro, PhD
Poster Number: 1466Date and
Time: Friday, November 15, 1:00 p.m. – 2:00 p.m.
PTLocation: San Diego Convention
CenterTitle: Bemnifosbuvir Does Not Alter
Cardiac Repolarization in Healthy Participants: Results from a
Thorough QT StudyPresenter: Xiao-Jian Zhou,
PhD
Poster Number: 1501Date and
Time: Friday, November 15, 1:00 p.m. – 2:00 p.m.
PTLocation: San Diego Convention
CenterTitle: Bemnifosbuvir Poses High Barrier
for Resistance in both Preclinical and Phase 1b Monotherapy
StudiesPresenter: Qi Huang, PhD
About Bemnifosbuvir
and Ruzasvir for Hepatitis C Virus (HCV)
Bemnifosbuvir has been shown in in
vitro studies to be approximately 10-fold more active than
sofosbuvir (SOF), against a panel of laboratory strains and
clinical isolates of HCV GT 1–5. In vitro studies have
also demonstrated bemnifosbuvir remained fully active against SOF
resistance-associated substitutions (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.
Bemnifosbuvir has been shown to have a low risk for drug-drug
interactions. Bemnifosbuvir has been administered to over 2,200
subjects and has been well-tolerated at doses up to 550 mg for
durations up to 12 weeks in healthy subjects and patients.
Ruzasvir has demonstrated highly
potent and pan-genotypic antiviral activity in preclinical
(picomolar range) and clinical studies. Ruzasvir has been
administered to over 1,500 HCV-infected patients at daily doses of
up to 180 mg for 12 weeks and has demonstrated a favorable safety
profile. The PK profile of ruzasvir supports once-daily dosing.
About Hepatitis C Virus (HCV)
Hepatitis C Virus (HCV) is a blood-borne, positive-sense,
single-stranded (ss)RNA virus that primarily infects liver cells.
HCV is a leading cause of chronic liver disease and liver
transplants, spreading via blood transfusion, hemodialysis and
needle sticks. An estimated 50 million people globally live with
chronic HCV infection, with approximately 1 million new infections
and 242,000 deaths occurring each year. Most HCV-related deaths are
due to liver scarring (cirrhosis) and liver cancer (hepatocellular
carcinoma). Injection drug use accounts for around 30% of new HCV
cases globally and approximately 60% in the U.S., where between 2-4
million people are estimated to have HCV. Annually, HCV diagnoses
in the U.S. outpace treatment rates, as less than a third of those
diagnosed with HCV receive timely treatment.
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 Atea’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. Our lead program and current focus is on the
development of the combination of bemnifosbuvir, a nucleotide
analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to
treat HCV. For more information, please
visit www.ateapharma.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements in this press release include but
are not limited to the anticipated date and time of the
presentations at The Liver Meeting, the anticipated timing for
reporting of the results from Atea’s Phase 2 trial of the
combination of bemnifosbuvir and ruzasvir in the treatment of
hepatitis C and the anticipated advancement of the program into
Phase 3 clinical development. When used herein, words including
“will,” “plans”, and similar expressions are intended to identify
forward-looking statements. In addition, any statements or
information that refer to expectations, beliefs, plans,
projections, objectives, performance or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking. All forward-looking statements
are based upon Atea’s current expectations and various assumptions.
Atea believes there is a reasonable basis for its expectations and
beliefs, but they are inherently uncertain. Atea may not realize
its expectations, and its beliefs may not prove correct. Actual
results could differ materially from those described or implied by
such forward-looking statements as a result of various important
factors, including, without limitation, dependence on the success
of Atea’s most advanced product candidates, in particular the
combination of bemnifosbuvir and ruzasvir for the treatment of
hepatitis C; as well as the other important factors discussed under
the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2024 as such factors may be updated
from time to time in its other filings with the SEC, which are
accessible on the SEC’s website at www.sec.gov. These and other
important factors 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
Atea may elect to update such forward-looking statements at some
point in the future, except as required by law, it disclaims any
obligation to do so, even if subsequent events cause our views to
change. These forward-looking statements should not be relied upon
as representing Atea’s views as of any date subsequent to the date
of this press release.
Contacts
Jonae BarnesSVP, Investor Relations and Corporate
Communications617-818-2985Barnes.jonae@ateapharma.com
Will O’ConnorPrecision
AQ212-362-1200will.oconnor@precisionaq.com
Atea Pharmaceuticals (NASDAQ:AVIR)
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