Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today provided an update
on the company’s clinical development programs for 2023, including
its strategic priorities and expectations for achievement of a
variety of milestones.
“Throughout 2022, our substantial clinical progress laid the
foundation for a milestone-rich 2023. With an exciting year ahead,
we expect to achieve a number of value-creating inflection points
across all three of our clinical development programs for COVID-19,
dengue and Hepatitis C,” said Jean-Pierre Sommadossi, PhD, Chief
Executive Officer and Founder of Atea
Pharmaceuticals. “Importantly, we have a strong balance sheet
from which to execute significant clinical milestones and to fund
operations through 2025.”
Bemnifosbuvir (AT-527) for COVID-19
SUNRISE-3 Global Phase 3 Registrational Study of
Bemnifosbuvir in High-Risk Non-Hospitalized Patients with
COVID-19: Patient enrollment continues in the
randomized, double-blind, placebo-controlled, global Phase 3
SUNRISE-3 study evaluating bemnifosbuvir or placebo administered
concurrently with locally available standard of care (SOC). The
study is designed to enroll at least 1,500 high-risk,
non-hospitalized patients with mild or moderate COVID-19, with an
expected global footprint of approximately 300 clinical trial sites
in the United States, Europe, Japan and rest of the world. Patients
will be randomized 1:1 to receive either bemnifosbuvir 550 mg
twice-daily (BID) plus locally available SOC or placebo BID plus
locally available SOC for five days. An interim analysis is
expected to be conducted in the second half of 2023.
This trial is comprised of two patient population cohorts
derived from the type of SOC received. These are 1) “Supportive
Care Population” (the patient does not qualify for an authorized
oral antiviral treatment or is in a region where oral antivirals
are not locally available) and bemnifosbuvir is evaluated as
monotherapy (primary analysis for registration) and 2) “Combination
Antiviral Population” which will assess combination therapy being
bemnifosbuvir plus SOC if the SOC includes treatment with other
COVID-19 antivirals (secondary analysis).
The primary endpoint of the study is all-cause hospitalization
or death through Day 29 in the supportive care population in at
least 1,300 patients. Secondary endpoints in each cohort include:
COVID-19 complications, medically attended visits, symptom rebound
/ relapse and viral load rebound.
The patient population will consist of those at the highest risk
for disease progression, including patients ≥ 80 years old,
patients ≥ 65 years old with ≥ one major risk factor, and
immunocompromised patients ≥ 18 years old, all regardless of
COVID-19 vaccination status.
COVID-19 Program for Second Generation Protease
Inhibitors: As part of a multipronged approach
against COVID-19, Atea is advancing an internal program focused on
the discovery of second-generation protease inhibitors that have
clinical profiles appropriate for combination with bemnifosbuvir
for the treatment of COVID-19. Atea’s target profile for a protease
inhibitor is a compound that is highly potent, has a favorable
safety profile with limited drug-drug interactions and does not
require a pharmacokinetic booster (e.g., ritonavir). The lead
optimization of compounds is ongoing for the selection of a
candidate that will next enter preclinical toxicology studies.
Atea’s goal for this program is to file an investigational new drug
application / clinical trial application for a lead compound at the
end of 2023.
The combination of bemnifosbuvir with the protease inhibitor
nirmatrelvir was examined in vitro in an HCoV-229E
surrogate model and results indicated an additive antiviral effect.
These data support the potential benefit of the combination of
bemnifosbuvir and a protease inhibitor for the treatment of
SARS-CoV-2 infection.
AT-752 Program Update for Dengue
Global Phase 2 Dengue Study and Human Challenge
Trial: Patient enrollment has been completed for the first
cohort in the global Phase 2 DEFEND-2
(DEngue Fever END)
trial of AT-752 for the treatment of dengue. The randomized,
double-blind, placebo-controlled study is designed to evaluate
multiple doses of AT-752 in three distinct cohorts (~n=20 per
cohort) and may enroll up to 60 adult patients infected with
dengue. The primary objective of the study is to assess antiviral
activity, with change from baseline dengue virus (DENV) viral load
as the primary endpoint [DENV RNA by reverse
transcription-polymerase chain reaction (RT-PCR)].
In addition, patient enrollment has been completed for the
dengue human challenge model. This trial is designed to evaluate
the effect of AT-752 in healthy volunteers who were challenged with
an attenuated DENV-1 virus strain after receiving AT-752 or
placebo.
Analysis of data from both studies is underway and
proof-of-concept results are expected in the first quarter of
2023.
Hepatitis C Virus (HCV) Program Update
Phase 2 HCV Combination Program: Regulatory
submissions for the Phase 2 combination study of bemnifosbuvir and
ruzasvir (RZR) are ongoing. Atea expects to initiate patient dosing
of the Phase 2 study during the second quarter of 2023 with initial
data anticipated in the fourth quarter of 2023. This study will
enroll approximately 280 HCV-infected, direct-acting antiviral
naive patients across all genotypes, including a lead-in cohort of
approximately 60 patients.
Patients will be administered 550 mg bemnifosbuvir in
combination with180 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.
Studies conducted by Atea have shown in vitro synergy
from the combination of bemnifosbuvir and RZR in inhibiting HCV
replication. In January 2022, Atea announced that it had obtained
exclusive worldwide rights to develop, manufacture and
commercialize RZR, an oral NS5A inhibitor, through a license
agreement with Merck.
About Atea PharmaceuticalsAtea is a clinical
stage biopharmaceutical company focused on discovering, developing
and commercializing oral therapies to address the unmet medical
needs of patients with severe diseases. 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 severe 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
difficult-to-treat, severe viral infections, including severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that
causes COVID-19, dengue virus and hepatitis C virus (HCV). For more
information, please visit www.ateapharma.com.
Forward-Looking StatementsThis 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, including
bemnifosbuvir combination 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 bemnifosbuvir as a potential treatment for COVID-19,
the combination of bemnifosbuvir and ruzasvir for the potential
treatment of HCV and AT-752 for the potential treatment of dengue.
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, 2021 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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