Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today announced
additional details on its clinical development plans for
bemnifosbuvir for the treatment of COVID-19. Following meetings
with the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) Emergency Task Force, Atea plans to initiate
a global Phase 3 registrational clinical trial of bemnifosbuvir for
the treatment of COVID-19 in the fourth quarter of 2022. The trial
will evaluate bemnifosbuvir as both monotherapy and combination
antiviral therapy in outpatients (non-hospitalized) with COVID-19
who are at the highest risk of disease progression, regardless of
vaccination status.
Bemnifosbuvir is an investigational orally administered,
non-mutagenic, non-teratogenic, direct-acting antiviral derived
from Atea’s purine nucleos(t)ide prodrug platform. Results from the
late-stage MORNINGSKY trial showed a 71% reduction in
hospitalization (secondary endpoint) with bemnifosbuvir versus
placebo (p=0.047, unadjusted, exploratory) (n=207). In a subgroup
analysis, patients > 40 years old had an 82% reduction in
hospitalization.
“This novel Phase 3 trial design puts us at the forefront of
clinical research for new COVID-19 antiviral therapies. In addition
to the potential for an approval of bemnifosbuvir as a COVID-19
monotherapy, this trial will move the treatment field forward for
combination antiviral therapy, which could be especially meaningful
for people at the highest risk of disease progression,” said
Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
Atea Pharmaceuticals. “There is a need for safe and convenient
therapies against COVID-19 for patients who may not benefit from
currently available therapies. Bemnifosbuvir’s results to-date,
including clinical benefits, favorable safety and tolerability, and
low risk of drug-drug interactions, demonstrate its potential to be
a cornerstone therapeutic for monotherapy and combination therapy
for the treatment of COVID-19.”
Bemnifosbuvir targets 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.
The inhibition of RNA polymerase has been shown in
vitro to effectively block production of SARS-CoV-2. In
addition, in vitro data confirm that bemnifosbuvir is
active with similar efficacy against all variants of concern or
interest that have been tested, suggesting antiviral activity
against future variants. Bemnifosbuvir’s unique mechanism with dual
targets is designed to create a high barrier to resistance.
Global Phase 3 Registrational Study Design
The randomized, double-blind, placebo-controlled, global Phase 3
study will evaluate bemnifosbuvir or placebo administered
concurrently with locally available standard of care (SOC). The
study is designed to enroll at least 1,500 high-risk
non-hospitalized patients with mild or moderate COVID-19. Patients
will be randomized 1:1 to receive either bemnifosbuvir 550 mg
twice-daily (BID) plus locally available SOC or placebo BID plus
locally available SOC for five days.
This trial will include two populations derived from the type of
SOC received. They include 1) “Supportive care population” (the
patient does not qualify for an approved antiviral treatment or
where antivirals are not locally available) which will assess
bemnifosbuvir given as monotherapy (primary analysis) and 2)
“Combination antiviral population” which will assess combination
therapy if the SOC includes treatment with other compatible
antiviral drugs against COVID-19 (secondary analysis).
The primary endpoint of the study is all-cause hospitalization
or death through Day 29 in the supportive care population in at
least 1,300 patients. Secondary endpoints in each patient
population include: COVID-19 complications, medically attended
visits, symptom rebound / relapse and viral load rebound.
The patient population will consist of those at the highest risk
for disease progression, including patients ≥ 80 years old,
patients ≥ 65 years old with ≥ one major risk factor, and
immunocompromised patients ≥ 18 years old, all regardless of
COVID-19 vaccination status.
The study is expected to have a global footprint with
approximately 300 clinical trial sites in the U.S., Europe, Japan
and rest of the world.
Conference Call and Webcast
Atea will host a conference call and live audio webcast today at
8:30 a.m. ET. To access the live conference call, please
register here. A live audio webcast of the call and
accompanying slide presentation will also be available in the
Events & Presentations section of the Company's Investor
Relations website. An archived webcast will be available on the
Atea website approximately two hours after the event.
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 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
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. 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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