Atea Pharmaceuticals Announces First Patient Dosed in Phase 2 Study for Treatment of Hepatitis C with Bemnifosbuvir and Ruzasvir Combination
15 Junho 2023 - 8:00AM
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 the dosing of the first patient in the
Phase 2 bemnifosbuvir and ruzasvir combination study for the
treatment of Hepatitis C Virus (HCV) infection.
“The initiation of this Phase 2 combination study marks an
important clinical milestone for Atea,” said Jean-Pierre
Sommadossi, PhD, Chief Executive Officer and Founder of Atea
Pharmaceuticals. “We believe the combination of bemnifosbuvir and
ruzasvir has the potential to significantly improve upon the
current standard of care by offering a short duration,
pan-genotypic, protease inhibitor-free treatment for patients with
HCV, with or without cirrhosis.”
The open label Phase 2 study is designed to enroll approximately
280 HCV-infected, direct-acting antiviral naive patients across all
genotypes, including a 60 patient lead-in cohort. Patients will be
administered 550 mg bemnifosbuvir in combination with 180 mg
ruzasvir once-daily for eight weeks. The primary endpoints of the
study are safety and sustained virologic response (SVR) at Week 12
post-treatment. Other virologic endpoints include virologic
failure, SVR at Week 24 post-treatment and resistance. Preliminary
data from the 60 patient lead-in cohort are anticipated in the
fourth quarter of 2023.
“Despite significant treatment advances, there remains a large,
underserved HCV patient population that continues to grow
dramatically due to the opioid crisis, injection drug use and HCV
reinfection. According to the World Health Organization, an
estimated 58 million people globally have chronic HCV infection,
about 1.5 million new infections occur per year and nearly 300,000
people die every year from HCV-related liver diseases,” added Dr.
Sommadossi.
About Hepatitis C Virus (HCV)
HCV is a blood-borne, positive sense, single stranded RNA virus,
primarily infecting cells of the liver. HCV is a leading cause of
chronic liver disease and liver transplants and spreads via blood
transfusion, hemodialysis and needle sticks. In the United States,
injection drug use accounts for approximately 60% of all new cases
of HCV. Diagnosis of HCV is made through blood tests, including
molecular tests that allow for the detection, quantification and
analysis of viral genomes and the classification of an infection
into specific viral genotypes. Infection becomes chronic in 75% to
85% of cases, with an incubation period lasting from two to 26
weeks.
HCV is classified into seven genotypes and 67 subtypes, with
genotype 1 being responsible for more than 70% of HCV cases in the
United States. Patients with HCV are also classified by liver
function status: compensated cirrhosis (liver scarring) denotes
those patients that do not yet have impaired liver function, while
decompensated cirrhosis describes patients with moderate to severe
liver function impairment.
The HCV patient population continues to grow dramatically in the
United States. A large portion of the current increase in incidence
is attributable to the opioid crisis, injection drug use and HCV
reinfection. The prevalence of HCV in the US is expected to
continue to remain steady over the coming years as rising HCV
incidence offsets the number of new patients treated. The HCV
market is estimated at approximately $3.5 billion in global net
sales in 2022, with approximately 50% attributable to the US.
About Bemnifosbuvir and
Ruzasvir for Hepatitis C
Virus
Bemnifosbuvir 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 resistant S282T and GT1a/3a NS5A
resistance associated variants (RAVs) tested and was shown to be at
least 10 times more potent than SOF. In clinical studies to date,
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. Rapid and highly potent
pan-genotypic antiviral activity was observed with bemnifosbuvir in
HCV infected subjects, regardless of cirrhosis status.
Ruzasvir (RZR), an oral NS5A inhibitor, has demonstrated highly
potent and pan-genotypic antiviral activity in preclinical
(picomolar range) and clinical studies. In vitro, ruzasvir retained
high potency against GT1a/3a NS5A RAVs and was shown to be 5
to10-fold more potent than velpatasvir. Ruzasvir has been
administered to over 1,200 HCV-infected patients at daily doses of
up to 180 mg for up to 24 weeks and has demonstrated a favorable
safety profile. Ruzasvir’s PK profile supports once-daily dosing.
The combination of bemnifosbuvir and ruzasvir for the treatment of
HCV is in Phase 2 development.
About Atea Pharmaceuticals
Atea is a clinical stage biopharmaceutical company focused on
discovering, developing and commercializing oral 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 is developing 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 through using its internal discovery capabilities
augmented by in-licensing. 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 our expectations surrounding the potential of our product
candidates, 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 ruzasvir as a potential treatment for HCV. 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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