Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today provided an update
on the company’s clinical development priorities for 2022,
including broadening its portfolio to include Phase 2 programs
across three severe viral diseases. Atea is planning a global Phase
2 outpatient trial for bemnifosbuvir (AT-527) in COVID-19 that is
designed to support anticipated combination trials. The Company is
also initiating development of ruzasvir (RZR), a Phase 2-ready,
next generation NS5A inhibitor in-licensed from Merck, in
combination with bemnifosbuvir as a pan-genotypic regimen for the
treatment of hepatitis C (HCV). In addition, Atea is advancing
AT-752 to a Phase 2 proof-of-concept program for the treatment of
dengue fever.
“We are executing on our strategy to build a leading antiviral
company that is able to address severe viral diseases. The
in-licensing of RZR supports the plan and enables the development
of a potentially best-in-class pan-genotypic hepatitis C regimen in
combination with bemnifosbuvir,” Jean-Pierre Sommadossi, PhD, Chief
Executive Officer and Founder of Atea Pharmaceuticals.
“Nucleos(t)ide drugs are the backbone for oral combination
treatment regimens which have had the greatest success in
combatting severe RNA viral diseases and we foresee that
bemnifosbuvir could also be a preferred backbone for protease
inhibitors to treat COVID-19.”
“We are expanding our pipeline in indications where we believe
we can make a meaningful difference for patients with severe viral
diseases. We expect to make important progress throughout the year
and to advance Phase 2 programs in the three key indications of
COVID-19, HCV and dengue fever,” said Janet Hammond, MD, PhD, Chief
Development Officer of Atea Pharmaceuticals. “Bemnifosbuvir’s
unique mechanism of action, combined with its efficacy and safety
profile to-date, make it an ideal candidate for combination therapy
with the potential to address unmet treatment needs for new waves
of COVID-19 and HCV patients. In addition, we are advancing AT-752
into a Phase 2 proof-of-concept program for dengue fever. We look
forward to reporting progress during the year with each of these
programs.”
Bemnifosbuvir
COVID-19 Clinical Development Program Update
Building on the positive findings from Phase 2 clinical studies
of bemnifosbuvir in high-risk patients with mild or moderate
COVID-19, Atea plans to initiate a Phase 2 outpatient study
designed to support anticipated clinical trials in combination with
a protease inhibitor. This Phase 2 trial is designed to obtain
additional safety, tolerability and virology data using a
formulation with faster dissolution and absorption to enrich the
data set from the previous Phase 2 studies. This trial is expected
to enroll up to 200 high-risk outpatients with mild to moderate
COVID-19. The Company expects to report topline data from this
Phase 2 study in late 2022. The Phase 2 outpatient study replaces
the Phase 2 study in hospitalized patients which Atea is currently
closing out.
In addition to the clinical development of bemnifosbuvir, Atea
is initiating preclinical in vitro combination studies of
bemnifosbuvir with protease inhibitors to explore antiviral synergy
and mitigation of potential viral resistance in connection with the
use of protease inhibitors for the treatment of COVID-19.
About Ruzasvir (RZR) and Hepatitis C (HCV) Program with
Bemnifosbuvir
Atea is announcing today that it has obtained exclusive
worldwide rights to develop, manufacture and commercialize RZR, an
oral NS5A inhibitor, through a recently completed license agreement
with Merck. Under the terms of the agreement, Atea will pay Merck
an upfront payment and Merck is eligible to receive additional
payments associated with the achievement of certain development and
commercial milestones as well as tiered royalties on product
sales.
RZR has demonstrated highly potent antiviral activity in the
picomolar range in preclinical studies. Clinical studies of RZR
conducted by Merck showed a > 3 log10 viral load decline in
HCV-infected patients as monotherapy. RZR has been administered to
over 1,250 HCV-infected patients at daily doses of up to 180 mg for
up to 24 weeks and has demonstrated a favorable safety profile with
no consistent treatment-related changes in laboratory parameters.
RZR’s pharmacokinetic (PK) profile supports once-daily dosing.
Bemnifosbuvir has been shown to be approximately 10-fold more
active than sofosbuvir (SOF) in vitro against a panel of laboratory
strains and clinical isolates of HCV genotypes 1–5. In vitro
studies demonstrated bemnifosbuvir remained fully active against
SOF resistance-associated strains (S282T), with up to 58-fold more
potency than SOF. Bemnifosbuvir has been shown to be generally well
tolerated in more than 480 subjects (including healthy volunteers
and patients with HCV or COVID-19). Bemnifosbuvir’s PK profile
supports once-daily dosing for the treatment of HCV.
In vitro studies conducted by Atea have demonstrated synergy
with bemnifosbuvir and RZR. Atea plans to initiate a Phase 2
combination study of bemnifosbuvir and RZR in the second half of
2022.
AT-752 Development Program for
Dengue Fever Update
Atea successfully completed the Phase
1 clinical trial of AT-752. In the Phase 1 trial, AT-752 was well
tolerated in 64 healthy subjects who were administered either
single or multiple doses. No premature discontinuations due to
adverse events or serious adverse events were reported and most
adverse events were mild and there were no changes in laboratory
parameters.
Atea plans to initiate a global Phase 2 proof-of-concept trial
and a human challenge study in the US during the first half of
2022. Atea expects to report results from these studies in late
2022.
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, 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 Atea’s expectations
surrounding the potential of our product candidates, including
bemnifosbuvir, AT-752 and RZR, and expectations regarding Atea’s
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 Atea’s actual results, performance or achievements to be
materially different from any anticipated 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
bemnifosbuvir as a potential treatment for COVID-19, the
development of bemnifosbuvir and RZR as a potential treatment for
HCV, and the development of AT-752 as a potential treatment for
dengue fever; dependence on management, directors and other key
personnel; the impact of the COVID-19 pandemic on our business;
Atea’s limited operating history and significant losses since
inception; Atea’s need for substantial additional funding; Atea’s
ability to use its net operating loss carryforwards; Atea’s
dependence on the success of its 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; Atea’s 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 Atea’s most recent
Quarterly Report on Form 10-Q and its 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
assumptions and expectations as of the date of this press release.
While Atea may elect to update such forward-looking statements at
some point in the future, it expressly disclaims any obligation to
do so, even if subsequent events cause management’s 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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