Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today announced the
enrollment of the first patient in the SUNRISE-3 Phase 3 trial, a
global multicenter trial evaluating bemnifosbuvir (AT-527) for the
treatment of COVID-19 in non-hospitalized patients at high risk for
disease progression to hospitalization and death. The patient was
enrolled and dosed at a U.S. clinical trial site. The study is
designed to enroll at least 1,500 patients with mild or moderate
COVID-19, and the primary endpoint is all-cause hospitalization or
death through Day 29 in at least 1,300 patients in the monotherapy
arm. Bemnifosbuvir is an investigational orally administered,
direct-acting antiviral derived from Atea’s purine nucleotide
prodrug platform.
“Our COVID-19 strategy for bemnifosbuvir is to focus on the
highest unmet medical need. Our goal is to deliver a safe,
effective and convenient treatment option for people that remain
vulnerable to hospitalization or death due to the limitations of
current antiviral treatments and the ability of the virus to evade
vaccines and monoclonal antibodies,” said Jean-Pierre Sommadossi,
PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals.
“New variants not susceptible to currently available preventive
tools are driving COVID-19 infection waves, which should enable
timely patient enrollment in SUNRISE-3.”
“COVID-19 remains a significant cause of morbidity and
mortality, particularly in the elderly and immunocompromised. New
oral antivirals, with improved profiles, are urgently needed to
help those for whom currently available treatments are either
unsuitable or ineffective,” said Robert Murphy, MD, Executive
Director of the Havey Institute for Global Health and the John
Philip Phair Professor of Infectious Diseases at Northwestern
University Feinberg School of Medicine.
Bemnifosbuvir, a nucleotide polymerase inhibitor, targets the
SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene that is
unlikely to change as the virus mutates and new variants continue
to emerge. This gene is responsible for both replication and
transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism
of action, with dual targets consisting of chain termination (RdRp)
and nucleotityltransferase (NiRAN) inhibition, which has the
potential to create a high barrier to resistance. In
vitro data confirm that bemnifosbuvir is active with similar
efficacy against all variants of concern or interest that have been
tested, including Omicron subvariants BA.4 and BA.5.
About the Phase 3 SUNRISE-3 TrialSUNRISE-3 is a
randomized, double-blind, placebo-controlled, global Phase 3 trial
to evaluate 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 a 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.
This trial will be comprised of two populations derived from the
type of SOC received. First, a “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)
which will assess bemnifosbuvir given as monotherapy. Second, a
“combination antiviral population” which will assess combination
therapy being bemnifosbuvir plus SOC if the SOC includes treatment
with other COVID-19 antivirals.
The primary endpoint of the study is all-cause hospitalization
or death through Day 29 in the supportive care population of at
least 1,300 patients evaluating bemnifosbuvir as monotherapy.
Secondary endpoints in the supportive care and combination
antiviral populations include: COVID-19 complications, medically
attended visits, symptom rebound / relapse and viral load rebound.
Hospitalization and death have been the endpoints highly preferred
by regulatory agencies, including the U.S. Food and Drug
Administration.
The patient population will consist of those at high risk for
disease progression, including patients ≥ 80 years old, patients ≥
65 years old with at least one major risk factor, and
immunocompromised patients ≥ 18 years old, all regardless of
COVID-19 vaccination status.
About Bemnifosbuvir for COVID-19Bemnifosbuvir
is an investigational orally administered, non-mutagenic,
non-teratogenic, direct-acting antiviral derived from Atea’s purine
nucleos(t)ide prodrug platform.
Results from the late-stage MORNINGSKY trial evaluating
bemnifosbuvir for the treatment of COVID-19, showed a 71% reduction
in hospitalization (secondary endpoint) with bemnifosbuvir versus
placebo (p=0.047, unadjusted, exploratory) (n=207). In a subgroup
analysis, patients > 40 years old had an 82% reduction in
hospitalization. To date, 650 subjects have been exposed to
bemnifosbuvir including 241 COVID-19 patients exposed to 550 mg or
higher doses BID for 5 days. Results demonstrate a favorable
profile, including clinical benefits in patient subsets, safety and
tolerability generally, and low risk of drug-drug interactions.
Bemnifosbuvir’s profile supports the potential for bemnifosbuvir
to become a cornerstone monotherapy and combination oral therapy
for the treatment of COVID-19.
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, hepatitis C virus (HCV), dengue virus and
respiratory syncytial virus (RSV). 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
and HCV and the clinical development of AT-752 for the potential
treatment or prevention 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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