Atea Pharmaceuticals Announces U.S. FDA Fast Track Designation Granted to Bemnifosbuvir, an Investigational Oral Antiviral, for the Treatment of COVID-19
April 25 2023 - 6:00AM
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company engaged in the discovery
and development of oral antiviral therapeutics for serious viral
diseases, today announced that the United States Food and Drug
Administration (FDA) has granted Fast Track designation (FTD) to
bemnifosbuvir for the treatment of COVID-19. Bemnifosbuvir is an
oral, direct-acting antiviral drug candidate being evaluated in the
global Phase 3 SUNRISE-3 registrational trial for the treatment of
COVID-19 in outpatients at high risk for disease progression
regardless of vaccination status. This includes patients over the
age of 80, patients 65 years or older with at least one major risk
factor, and anyone over the age of 18 who is immunocompromised.
“The decision to grant FTD by the FDA for bemnifosbuvir reflects
the continuing unmet medical need that remains for COVID-19
patients. FTD has the potential to expedite the development of
bemnifosbuvir and we look forward to ongoing discussions with the
FDA,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and
Founder of Atea Pharmaceuticals. “Due to the limitations of current
antiviral treatments, including drug-drug interactions and
potential risks for genotoxicity and reproductive toxicity, as well
as the ability of the virus to evade vaccines and monoclonal
antibodies, new treatment options are urgently needed. In
SUNRISE-3, we are targeting the most vulnerable patient populations
who are at the greatest risk for disease progression to severe
COVID-19 or mortality, and for whom there are currently the fewest
treatment options.”
About Bemnifosbuvir Fast Track Designation
The FDA’s Fast Track program is designed to facilitate the
expedited development and review of new drugs or biologics that are
intended to treat serious or life-threatening conditions and
demonstrate the potential to address unmet medical needs. Among
other things, as a result of the Fast Track designation, Atea may
benefit from more frequent communications with the FDA to discuss
the development plan of bemnifosbuvir for the treatment of COVID-19
and rolling review of any completed sections of any resulting New
Drug Application (NDA).
About the Phase 3 SUNRISE-3 Trial
SUNRISE-3 is a randomized, double-blind, placebo-controlled,
global Phase 3 trial designed to evaluate bemnifosbuvir or placebo
administered concurrently with locally available standard of care
(SOC). It is expected that the study will enroll at least 1,500
high-risk, outpatients with mild or moderate COVID-19, with a
global footprint of approximately 300 clinical trial sites planned
in the United States, Europe, Japan and rest of the world. 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 is comprised of two populations derived from the type
of SOC received. First, a “supportive care population” (the patient
does not qualify for an authorized oral antiviral treatment or is
in a region where oral antivirals are not locally available) which
will assess bemnifosbuvir given as monotherapy. Second, a
“combination antiviral population” which will assess combination
therapy being bemnifosbuvir plus SOC if the SOC includes treatment
with other COVID-19 antivirals.
The primary endpoint of SUNRISE-3 is all-cause hospitalization
or death through Day 29 in the supportive care population of at
least 1,300 patients evaluating bemnifosbuvir as monotherapy.
Secondary endpoints in both the supportive care and combination
antiviral populations include: COVID-19 complications, medically
attended visits, symptom rebound / relapse and viral load
rebound.
The patient population enrolling in SUNRISE-3 consists of those
at high risk for disease progression, including patients ≥ 80 years
old, patients ≥ 65 years old with at least one major risk factor,
and immunocompromised patients ≥ 18 years old, all regardless of
COVID-19 vaccination status.
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 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 confirmed 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 is developing 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 through using its internal discovery capabilities
augmented by in-licensing. 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
bemnifosbuvir as treatment for COVID-19 and the potential of the
FTD to expedite its development. 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 timelines and costs associated
with the clinical development of bemnifosbuvir as a potential
treatment for COVID-19. 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
Atea Pharmaceuticals (NASDAQ:AVIR)
Historical Stock Chart
From Apr 2024 to May 2024
Atea Pharmaceuticals (NASDAQ:AVIR)
Historical Stock Chart
From May 2023 to May 2024