Atea Pharmaceuticals Introduces New Strategic Clinical Development Program for AT-527 in COVID-19
December 14 2021 - 4:30PM
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today announced an
updated strategy for AT-527 to address the rapidly evolving
SARS-CoV-2 and emerging variants by maximizing the compound’s
unique profile for potential use as both a monotherapy and
in combination. Taking into account the changing COVID-19
landscape with the anticipated availability of new antiviral
treatment regimens, the global Phase 3 MORNINGSKY trial will be
closed out and the ongoing Phase 2 hospitalized trial will be
further amended to expand enrollment to unvaccinated, high-risk
outpatients. Atea expects to provide a more detailed update on its
strategy and new development plan in 2022.
“We believe strongly in AT-527’s potential to combat the
evolving SARS-CoV-2 and emerging variants as a monotherapy and as
an important backbone in potential combination therapy,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “Our new strategy enables us to rapidly drive
forward a plan to maximize AT-527’s unique profile with a
development approach designed to meet the current and future needs
of COVID-19, which may include the emergence of new variants and
drug resistance to other therapies.”
“The nucleoside class has been the cornerstone of effective oral
antiviral combination treatments for severe viral diseases, and we
are preparing for a future where combination regimens may be needed
to treat COVID-19 as the virus and pandemic evolve. Importantly, we
have the financial and internal resources to execute this strategy
through key clinical and regulatory inflection points,” added Dr.
Sommadossi.
“After careful consideration of the rapid evolution of
SARS-CoV-2 and the emergence of variants combined with the
increasing availability of new COVID-19 treatment options,
including the anticipated new antiviral regimens, continuing the
MORNINGSKY trial is not the most effective path forward,” said
Janet Hammond, MD, PhD, Chief Development Officer of Atea
Pharmaceuticals. “Our new development plan will leverage AT-527’s
unique profile with the objective to advance an oral,
best-in-class, drug candidate that can be used broadly for the
treatment of coronaviruses and for future pandemic
preparedness.”
Atea will continue to advance the global AT-527 Phase 2 trial
evaluating the safety, tolerability and virological activity of
AT-527 in unvaccinated patients with risk factors with moderate
COVID-19. This ongoing study is currently exploring doses up to
1,100 mg BID in patients who are managed in a hospitalized or
confined setting. Atea intends to further amend this study to
remove the requirement for patient confinement or hospitalization.
The amended Phase 2 trial is expected to enroll up to 200 patients.
Atea anticipates reporting data from this trial during
2022. In addition, Atea is initiating preclinical in vitro
combination studies of AT-527 and other compounds with different
mechanisms of action to evaluate additive and synergistic
benefits.
In addition to MORNINGSKY, the follow-on MEADOWSPRING trial will
also be closed out. The strategic collaboration with Roche will be
terminated on February 10, 2022.
About the AT-527 COVID-19
Clinical Development Program
Derived from Atea’s nucleos(t)ide
prodrug platform, AT-527 is an oral direct-acting antiviral which
is being studied to determine its potential to protect against
disease progression and the development of long-COVID
complications. Its unique mechanism of action, with dual targets
including chain termination (RdRp) and NiRAN inhibition, has the
potential to create a high barrier to resistance with broad
antiviral coverage to different variants of SARS-CoV-2. Atea has
completed a comprehensive nonclinical program to characterize the
safety profile of AT-527. Results observed from these nonclinical
studies demonstrated that AT-527 was non-mutagenic, had no effects
on fertility or reproduction and was non-teratogenic.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical
company focused on discovering, developing and commercializing oral
therapies to address the unmet medical needs of patients with
life-threatening viral diseases. Leveraging the Company’s deep
understanding of antiviral drug development, nucleos(t)ide
chemistry, biology, biochemistry and virology, Atea has built a
proprietary nucleotide 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.
Currently, Atea is focused on the development of orally-available,
potent, and selective nucleotide prodrugs for difficult-to-treat,
life-threatening viral infections, including severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that
causes COVID-19, dengue virus, hepatitis C virus (HCV) and
respiratory syncytial virus (RSV). 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, including
AT-527 and AT-752, 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 following: uncertainty around and costs
associated with the development of AT-527 as a potential treatment
for COVID-19 and our other product candidates; dependence on
management, directors and other key personnel; the impact of the
COVID-19 pandemic on our business; our limited operating history
and significant losses since inception; our need for substantial
additional funding; our ability to use our net operating loss
carryforwards; our dependence on the success of our most advanced
product candidates; risks related to the regulatory approval
process; risks associated with the clinical development process and
reliance on interim or topline clinical trial results; risks
related to healthcare laws and other legal compliance matters;
risks related to potential commercialization; risks related to
manufacturing and our dependence on third parties; risks relating
to intellectual property; our ability to maintain effective
internal control over financial reporting and the significant costs
as a result of operating as a public company. These and other
important factors discussed under the caption “Risk Factors” in our
most recent Quarterly Report on Form 10-Q, 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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