Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company engaged in the discovery
and development of oral direct acting therapeutics for serious
viral diseases, today announced the presentation of the full
results from the MORNINGSKY Phase 3 trial evaluating bemnifosbuvir
for the treatment of COVID-19. These results are being presented at
the 33rd European Congress of Clinical Microbiology &
Infectious Diseases (ECCMID), which is taking place April 15-18,
2023 in Copenhagen, Denmark. Bemnifosbuvir is an investigational,
oral, direct-acting antiviral being developed for the treatment of
COVID-19.
“With MORNINGSKY, in both low- and high-risk patients receiving
bemnifosbuvir regardless of vaccination status, we see lower rates
of hospitalization which is a clinically meaningful outcome,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “The MORNINGSKY data also highlight
additional potential clinical benefits of bemnifosbuvir. We believe
these data, together with bemnifosbuvir’s favorable safety and
drug-drug interaction profile, underscore its potential to address
key unmet medical needs and limitations of current therapies for
the treatment of COVID-19.”
The MORNINGSKY results showed that non-hospitalized adult and
adolescent patients receiving bemnifosbuvir for the treatment of
mild to moderate COVID-19 experienced a 71% relative reduction in
risk of hospitalization, regardless of vaccination status. In an
exploratory analysis, an 82% reduction for hospitalization was seen
in a subset of patients greater than 40 years of age. Topline
results from the MORNINGSKY study were announced in May 2022.
Although the MORNINGSKY Phase 3 trial did not meet its primary
endpoint of improved time for alleviation of COVID-19 symptoms, it
was observed that patients treated with bemnifosbuvir experienced
lower rates of hospitalization, medically attended visits,
COVID-19-related complications and post treatment infections
compared to patients receiving placebo. In this trial,
bemnifosbuvir was generally safe and well tolerated, and there were
no treatment related serious adverse events. Adverse events leading
to treatment discontinuation were observed in 2.8% of patients
treated with bemnifosbuvir compared to 7% of patients receiving
placebo. Data from in vitro studies have demonstrated that
bemnifosbuvir has no teratogenic or mutagenic effects and data from
Phase 1 studies have shown low potential for bemnifosbuvir
drug-drug interactions.
Based on these data, the global Phase 3 SUNRISE-3 registrational
trial was initiated with an all-cause hospitalization or death
primary endpoint in a high-risk population. Data presented at the
36th International Conference on Antiviral Research (ICAR) in March
further support bemnifosbuvir’s favorable safety and drug
interaction profile.
Atea will also present clinical data for AT-752, an oral double
prodrug of a guanosine nucleotide analog for the treatment of
dengue virus, at ECCMID 2023. As part of a Phase 1 single and
multiple ascending dose study, which evaluated the safety,
tolerability and pharmacokinetics of AT-752, a concentration-QTc
(C-QTc) analysis was conducted. Results indicated that AT-752 did
not affect cardiac repolarization in healthy participants and that
AT-752 was well tolerated after single and multiple oral doses.
Bemnifosbuvir for COVID-19
Poster Number: P2629
Date/Time: Monday, April 17, 2023,12:00 pm
CETTitle: Bemnifosbuvir (AT-527) Treatment of
Non-Hospitalized Individuals with Mild to Moderate COVID-19:
Results from a Truncated Phase 3, Randomized, Double-Blind,
Placebo-Controlled Trial (MORNINGSKY)
MORNINGSKY results showed that both vaccinated and unvaccinated
patients with low and high risk for COVID-19 disease progression
experienced a 71% relative reduction in risk of hospitalization
with bemnifosbuvir (n=137) versus placebo (n=70). In an exploratory
analysis of high-risk patients (greater than 40 years old; median
age was 41 years old), there was an 82% relative risk reduction.
Bemnifosbuvir was generally well tolerated.
MORNINGSKY was a randomized, double-blind, multi-center,
placebo-controlled Phase 3 trial evaluating the efficacy, safety,
antiviral activity, and pharmacokinetics of bemnifosbuvir in
patients with mild to moderate COVID-19 randomized 2:1 to receive
bemnifosbuvir 550 mg twice-daily or placebo in an outpatient
setting. The primary endpoint of time to symptom alleviation was
not met, however, a key secondary clinical efficacy endpoint showed
a meaningful relative risk reduction in hospitalization and
additional secondary clinical efficacy endpoints showed lower rates
of COVID-19-related complications, medically attended visits, and
post treatment infections compared with placebo. No clear
differences in any of the virology endpoints between the
bemnifosbuvir and placebo arms were observed. There were no deaths
in the trial. As announced in December 2021, MORNINGSKY was closed
out early, having enrolled 216 patients of which 207 patients were
evaluable for efficacy. Bemnifosbuvir is currently being evaluated
in the global Phase 3 SUNRISE-3 registrational trial
(NCT05629962).
AT-752 for Dengue
Poster Number: P2941Date/Time:
Monday, April 17, 2023,12:00 pm CETTitle: AT-752,
A Novel Nucleotide Prodrug With Pan-Serotype Activity Against
Dengue Virus, Does Not Affect Cardiac Repolarization: Results From
a Robust QT/QTc Evaluation in Healthy Participants
Results in healthy subjects (n=49) demonstrated that AT-752 was
well tolerated and had no clinically relevant effects on cardiac
repolarization, heart rate, PR (time between atrial depolarization
and ventricular depolarization) or QRS (ventricular depolarization)
intervals. The results showed that a QTc effect (in
electrocardiography, the duration of the QT interval adjusted for
the participant’s heart rate) exceeding 10 milliseconds is unlikely
across the full observed plasma concentration ranges of AT-281
(free base of AT-752) and metabolites.
While preclinical in vitro and in vivo data and the results from
clinical trials indicate a favorable biological, pharmacological
and safety profile for AT-752, Atea made the business decision in
February 2023 to focus on its COVID-19 and hepatitis C virus (HCV)
programs and to deprioritize its dengue program and the clinical
development of AT-752.
About Bemnifosbuvir for COVID-19
Bemnifosbuvir, a nucleotide polymerase inhibitor, targets the
SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene that is
unlikely to change as the virus mutates and new variants continue
to emerge. This gene is responsible for both replication and
transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism
of action, with dual targets consisting of inhibition of RNA
dependent RNA polymerase (RdRp) and nucleotityltransferase (NiRAN),
which has the potential to create a high barrier to resistance. In
vitro data confirm that bemnifosbuvir is active with similar
efficacy against all variants of concern and variants of interest
that have been tested, including Omicron subvariants BA.4 and BA.5.
Bemnifosbuvir is currently being evaluated in SUNRISE-3, a global
multicenter Phase 3 registrational trial for the treatment of
COVID-19.
About Atea Pharmaceuticals
Atea is a clinical stage biopharmaceutical company focused on
discovering, developing and commercializing oral therapies to
address the unmet medical needs of patients with serious viral
infections. 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 serious 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 serious viral infections,
including severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), the virus that causes COVID-19, and hepatitis C virus
(HCV). 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 for the treatment of COVID-19.
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. 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, 2022 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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