Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today reported that the
global Phase 2 MOONSONG trial evaluating AT-527 in the outpatient
setting did not meet the primary endpoint of reduction from
baseline in the amount of SARS-CoV-2 virus in patients with mild or
moderate COVID-19 compared to placebo in the overall study
population, of which approximately two thirds of patients were
low-risk with mild symptoms. However, in high-risk patients with
underlying health conditions, a reduction of viral load of
approximately 0.5 log10 at Day 7 was observed at 550 mg
(prespecified subgroup analysis) and 1,100 mg BID (exploratory
subgroup analysis) compared with placebo.
Based on the MOONSONG topline and additional recent results for
AT-527 as well as the evolving COVID-19 environment, Atea, together
with Roche, are assessing potential modifications to the global
Phase 3 MORNINGSKY trial including the trial’s primary endpoint and
patient population. As a result, we now anticipate Phase 3
MORNINGSKY data in the second half of 2022.
“The primary endpoint was not achieved in the overall study
population in patients with mild or moderate COVID-19, however,
MOONSONG topline data suggest that AT-527 has antiviral activity in
high-risk patients with underlying health conditions as we
previously reported in the Phase 2 hospitalized study. Based on
these and other AT-527 data, we with our partner Roche, are
assessing potential modifications to the Phase 3 MORNINGSKY
protocol that may likely lead to improved clinical outcomes,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “We remain committed to our goal of
developing and delivering AT-527 as an oral antiviral that will
address treatment needs as COVID-19 continues to evolve.”
Atea and Roche are jointly developing AT-527 as an oral
direct-acting antiviral (DAA) for the treatment of COVID-19. 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 from these nonclinical studies
demonstrate that AT-527 is non-mutagenic and has no effects on
fertility and reproduction.
Topline Results of Global Phase 2 MOONSONG Trial of
AT-527 in the Outpatient Setting
The global Phase 2 MOONSONG trial is a randomized, double-blind,
multi-center, placebo-controlled trial, evaluating the antiviral
activity, safety and pharmacokinetics of AT-527 550 mg (Cohort A,
n=30) and 1,100 mg (Cohort B, n=30) administered twice daily (BID)
in adult patients with mild or moderate COVID-19 versus placebo
(n=40). The primary endpoint of this virology trial, which enrolled
patients who were SARS-CoV-2 positive, is change from baseline in
amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified
timepoints.
In the topline analysis, treatment with AT-527 did not meet the
primary endpoint as it did not show a clear reduction in SARS-CoV-2
viral load in the overall population of patients with mild or
moderate COVID-19 compared to placebo. Overall, approximately
two-thirds of the patients had mild symptoms with no underlying
health conditions and were on average 37 years old. Additionally,
COVID-19 vaccinated patients were among the patients included in
the overall study population.
In high-risk patients with underlying health conditions, a
reduction of viral load of approximately 0.5 log10 at Day 7 was
observed with administration of 550 mg as compared to placebo
(prespecified subgroup analysis Cohort A n=7; placebo n=11) and
with administration of 1,100 mg BID as compared to placebo
(exploratory subgroup analysis Cohort B; n=14; placebo n=7).
In addition to baseline patient characteristics, several factors
may have impacted the MOONSONG data results, which evaluated viral
kinetics. These potential factors include different variants
emerging during the study, greater penetration of vaccinations
within the enrolled population and a pooled placebo patient
population. The pooled placebo patient population included
different vaccination status (varying doses and vaccine types) and
may have included different COVID-19 variants.
Consistent with previous studies, AT-527 was generally safe and
well tolerated. In the MOONSONG study, the proportion of patients
experiencing any adverse event (AE) was 20% in the placebo group,
20% in the AT-527 550 mg BID group (Cohort A) and 27% in the AT-527
1100 mg BID group (Cohort B). There were 3 non-drug related
serious adverse events (SAEs) in each of the treatment groups and
all other AEs were grade 1 or 2. Gastrointestinal (GI)-related AEs
were the most commonly reported AEs: 8% in the placebo group; 7% in
the AT-527 550 mg BID group (Cohort A); 17% in the AT-527 1100 mg
BID group (Cohort B), with mild to moderate nausea/vomiting
resulting in premature study drug discontinuation of 3% in the
placebo group, 0% in the AT-527 550 mg BID group (Cohort A) and 17%
in the AT-527 1100 mg BID group (Cohort B). No clinically
significant differences in laboratory abnormalities were observed
in the treatment arms as compared to placebo.
“Based on the totality of the results for AT-527 to-date, the
current level of understanding of the virus and the evolving
COVID-19 environment, we are assessing the Phase 3 MORNINGSKY trial
for modifications to ensure the best possible outcome for the
program,” said Janet Hammond, MD, PhD, Chief Development Officer of
Atea Pharmaceuticals. “We, along with our partner Roche, are
continuing to advance multiple studies in parallel to provide
further clinical evidence as well as outcome data to support AT-527
as an oral, potent, direct-acting antiviral treatment for
COVID-19.”
In addition to the MOONSONG results announced today, results
from the bronchoalveolar lavage study and Phase 2 hospitalized
trial are being presented at the International Society for
Influenza and Other Respiratory Virus Diseases (ISIRV)-World Health
Organization Virtual Conference (WHO), in a poster and oral session
held virtually October 19-21, 2021.
Conference Call and Webcast
Atea will host a conference call and live audio webcast to
discuss these data today at 8:30 a.m. ET. To access the live
conference call, please dial (833) 301-1150 (domestic) or (914)
987-7391 (international) at least five minutes prior to the start
time and refer to conference 1186883.
A live audio webcast of the call and accompanying slide
presentation will also be available in the Investors’ Events &
Presentations section of the Company's website, www.ateapharma.com.
An archived webcast will be available on the Atea website
approximately two hours after the event.
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 mechanism of action,
with dual targets against a key viral enzyme, enhances its
potential to limit resistance and work across variants. In
collaboration with Roche, Atea is evaluating AT-527 across multiple
Phase 2 and Phase 3 clinical trials that are advancing in parallel,
including the global Phase 3 MORNINGSKY trial, a global Phase 2
study in hospitalized patients with moderate COVID-19, and the
global Phase 2 MOONSONG virology study in patients with mild or
moderate COVID-19 in an outpatient setting. In addition,
MEADOWSPRING, a global Phase 3 long-term follow-on study, is
evaluating the impact of AT-527 on long-term sequelae of COVID-19
in patients previously enrolled in MORNINGSKY.
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, AT-527, 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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