Atea Pharmaceuticals Announces First Patient Dosed in Global Phase 3 MORNINGSKY Trial of AT-527 for Treatment of COVID-19
April 29 2021 - 2:00AM
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today announced that
the first patient has been dosed in the Phase 3 MORNINGSKY trial, a
global multicenter trial evaluating AT-527 in mild or moderate
COVID-19 patients in an outpatient setting. The trial, which is
anticipated to enroll approximately 1,400 non-hospitalized adults
and adolescents with mild to moderate COVID-19, is currently
enrolling patients at clinical trial sites outside the United
States. MORNINGSKY is expected to have an extensive global
footprint and will include a large number of clinical sites
worldwide, including Japan.
AT-527 is an orally administered, direct-acting antiviral in
development and derived from Atea’s purine nucleotide prodrug
platform. Under a strategic collaboration, Roche and Atea are
jointly developing AT-527 for the treatment of COVID-19.
“This pivotal milestone demonstrates a
focused effort with our strategic partner Roche to globally advance
the development of an oral therapeutic for COVID-19 that has the
potential for broad use in early stages of the disease,” said
Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer
of Atea Pharmaceuticals. “With the initiation of this global Phase
3 program, we are one step closer to achieving our goal of
providing an easily administered oral, direct-acting antiviral in
the fight against this global pandemic.”
Dr. Sommadossi continued, “As a direct-acting
antiviral, AT-527 aims to prevent disease progression by inhibiting
viral replication and thereby reducing the severity of disease,
preventing or shortening hospitalization, and also potentially
preventing transmission of the virus to others. This makes it
well-suited for potential use in both pre- and post-exposure
prophylactic settings and complementary to vaccines.”
AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase
(nsp12), a highly conserved gene which is responsible for both
viral RNA replication and transcription. Given this preferential
conserved target site, it is anticipated that the antiviral
activity of AT-527 will continue even in the presence of
naturally-evolving variants, which are now spreading globally.
About the Phase 3 MORNINGSKY
Trial
MORNINGSKY is a Phase 3 multicenter,
randomized, double-blind, placebo-controlled, outpatient study to
evaluate the efficacy, safety, pharmacokinetic profile and
antiviral activity of AT-527 in patients with mild or moderate
COVID-19. The study is expected to enroll approximately 1,400
non-hospitalized patients, including adolescents with confirmed
mild to moderate acute respiratory syndrome coronavirus-2
(SARS-CoV-2) infection. Patients will be randomized within 5 days
of symptom onset. At the time of enrollment, patients must be
stable and not require hospitalization. The primary endpoint,
evaluating the efficacy of AT-527 compared with placebo, will
measure the time to alleviation or improvement of COVID-19
symptoms. Other efficacy endpoints will include number of patients
requiring medically attended visits or hospitalization for
COVID-19. Additionally, among other secondary and exploratory
endpoints, the study will also identify and/or evaluate biomarkers
that are predictive of an antiviral response to AT-527.
About the AT-527 COVID-19 Clinical Development
Program
AT-527 is an orally administered, direct-acting antiviral agent
derived from Atea’s nucleotide prodrug platform. AT-527 is
currently under evaluation as a treatment for patients with
COVID-19. In collaboration with Roche, in addition to the Phase 3
MORNINGSKY trial, AT-527 is currently being evaluated in a global
Phase 2 study for hospitalized patients with moderate COVID-19 and
a Phase 2 virology study in patients with mild or moderate COVID-19
in an outpatient setting.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical
company focused on discovering, developing and commercializing
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 safety, efficacy and
demand for our product candidates, in particular AT-527; plans and
timing for clinical trials and data; our strategic collaboration
with Roche; our leadership; the sufficiency of our cash and cash
equivalents to fund our operations; our competitive position and
our participation in upcoming presentations and conferences. 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; 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;
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 Annual Report on Form 10-K for the year ended
December 31, 2020 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
Investors:
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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