Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today announced that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
Designation to AT-752, a novel, orally administered, direct-acting
antiviral for the treatment of dengue virus infection.
AT-752, a novel, orally administered direct-acting antiviral
derived from Atea’s purine nucleotide prodrug platform was designed
for the treatment and prophylaxis of dengue. It works by impairing
the dengue viral polymerase, which then inhibits replication of the
virus. AT-752 is in Phase 2 clinical development and was generally
well tolerated in a Phase 1 clinical study. In preclinical studies,
AT-752 showed potent in vitro activity against all dengue
serotypes, as well as potent in vivo antiviral activity in a small
animal model.
“This Fast Track Designation underscores the urgent need for the
development of effective treatments for this potentially severe
viral disease as there are no currently approved treatments,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “This designation creates a potential
opportunity to accelerate our efforts to develop AT-752 to address
a critical unmet need for people worldwide.”
“Dengue is the most prevalent mosquito-borne virus affecting up
to 400 million people annually and is a substantial public health
and economic burden worldwide. Dengue causes a severe generalized
illness with fever which may require hospitalization and is
associated with mortality. It is caused by an RNA virus which is
transmitted by mosquitoes and may result in the potentially fatal
clinical syndrome called dengue hemorrhagic fever,” said Janet
Hammond, MD, PhD, Chief Development Officer of Atea
Pharmaceuticals. “We are advancing two proof-of-concept studies to
demonstrate AT-752’s safety and efficacy for the treatment and
prophylaxis of dengue and look forward to initial data around the
end of this year.”
About AT-752 Fast Track Designation
The FDA’s Fast Track program facilitates the expedited
development and review of new drugs or biologics that are intended
to treat serious or life-threatening conditions and demonstrate the
potential to address unmet medical needs. Among other things, as a
result of the Fast Track designation, Atea may benefit from more
frequent communications with the FDA to discuss the development
plan of AT-752 for the treatment of dengue virus infection and
rolling review of any completed sections of a resulting New Drug
Application (NDA).
About the AT-752 Clinical ProgramAtea is
currently conducting two clinical studies of AT-752. The first
study is a global, randomized, double-blind, placebo-controlled
Phase 2 trial in adult patients with dengue virus infection. The
study is designed to evaluate the antiviral activity, safety and
pharmacokinetics of multiple doses of AT-752 in areas where dengue
is endemic. The second study is a human challenge study that is
being conducted in the United States. The challenge study is
designed to evaluate healthy subjects who are challenged with a
Dengue Virus-1 Live Attenuated Virus strain after receiving AT-752
or placebo.
About Dengue
It is estimated that dengue accounts for up to 400 million
infections a year globally, of which 100 million people get sick
from the infection1 and 500,000 cases2 develop into
life-threatening dengue hemorrhagic fever. Dengue infection is
currently endemic in equatorial regions of the world, including
Puerto Rico, Southeast Asia, Latin America and the Pacific Islands.
Dengue occurs occasionally in the continental U.S. and other areas
outside the endemic regions. However, because the types of
mosquitoes that spread dengue are common in many parts of the
continental U.S., local spread of the disease is possible. In
addition, intercontinental jet transport, immigration, tourism,
military operations and mosquito migration are increasing the
direct effect of dengue on the global population.
Four serotypes of dengue viruses (DENV1–4) are common and a
fifth serotype has been isolated but is yet to be fully
characterized. As dengue serotypes are sufficiently different
antigenically, infection with one serotype will confer lifelong
immune protection against that serotype only, with only temporary,
partial cross-immunity to other serotypes following recovery. A
person can therefore potentially be infected with each of the four
dengue serotypes in their lifetime. Subsequent infections with
other serotypes increase the risk of developing severe disease due
to antibody-dependent enhancement (ADE).
The World Health Organization has called dengue the most
important mosquito-borne viral disease in the world. The FDA,
together with other governmental and non-governmental agencies,
recognize dengue as a substantial and growing global public health
burden. Dengue is defined as a tropical disease under the U.S.
Food, Drug and Cosmetic Act and, therefore, FDA approval of AT-752
for the treatment or prevention of dengue may result in the award
of a tropical disease priority review voucher that may be used for
a subsequent NDA or biologics license application.
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
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 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-752, and expectations regarding the
potential benefits of AT-752 for the treatment or prophylaxis of
dengue virus infection, anticipated timing of initial clinical data
from the ongoing clinical trials of AT-752 and the possibility that
AT-752, if approved, may result in the award of a priority voucher.
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 AT-752 as a
potential treatment or prophylaxis for dengue virus infection.
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
1 https://www.cdc.gov/dengue/about/index.html2
https://apps.who.int/mediacentre/factsheets/fs117/en/index.html
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