Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today presented a poster
highlighting favorable AT-752 Phase 1 clinical data for the
treatment of dengue fever at the American Society of Tropical
Medicine & Hygiene (ASTMH) 2022 Annual Meeting in Seattle,
Washington.
The poster #1358, titled “Safety, tolerability, and
pharmacokinetics of AT-752, a novel nucleotide prodrug with
pan-serotype activity against dengue virus: results from a Phase 1,
first-in-human, dose-escalation study,” was presented by Xiao-Jian
Zhou, PhD, Executive Vice President of Early Stage Development at
Atea Pharmaceuticals.
“Dengue is the most prevalent mosquito-borne virus and despite
its alarming increase over the last two decades, there are no
direct-acting antiviral treatments available,” said Jean-Pierre
Sommadossi, PhD, Chief Executive Officer and Founder of Atea
Pharmaceuticals. “These data demonstrate that AT-752 was well
tolerated up to the highest dose tested and rapidly achieved plasma
levels above the in vitro EC90. Based on these data, we anticipate
that AT-752 may have the potential to rapidly inhibit dengue virus
replication across all serotypes (1-5). In addition, AT-752
exhibited no pharmacokinetic sensitivity across varying ethnic
populations participating in the trial.”
“Importantly, these results support our advancement of two
proof-of-concept studies to demonstrate AT-752’s safety and
efficacy for the treatment and potential prophylaxis of dengue,”
continued Dr. Sommadossi.
Atea is currently conducting two AT-752 clinical studies. 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 (PK) 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.
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. 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.
The U.S. Food and Drug Administration (FDA) has granted Fast
Track Designation to AT-752 for the treatment of dengue virus
infection.
AT-752 Phase 1 Study Results
In the Phase 1 study, 65 healthy subjects aged 18–65 years old
were sequentially enrolled into single ascending dose (SAD) and
multiple ascending dose (MAD) cohorts and randomized to receive
oral AT-752 or placebo. AT-752 was administered as a single oral
dose up to 1500 mg, or as multiple oral doses up to 750 mg three
times a day. In this study, AT-752 rapidly achieved plasma levels
exceeding the in vitro EC90. AT-752 was generally safe and well
tolerated and no premature discontinuations due to adverse events
or serious adverse events were reported. Most adverse events were
mild and there were no clinically relevant changes in laboratory
parameters. AT-752 exhibited no PK sensitivity across varying
ethnic populations participating in the trial and no food effect
was seen.
The overall safety and PK results obtained in this Phase 1 study
supported the initiation of two clinical studies of AT-752 for the
treatment and prophylaxis of dengue infection.
About Dengue Fever
It is estimated that dengue accounts for up to 400 million
infections a year globally, of which 100 million people get sick
from the infection and 500,000 cases 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 dengue
serotype 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 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 AT-752 for the potential
treatment and 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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