Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today announced that data
from three Phase 1 studies suggest a favorable drug-drug
interaction profile. No dosage adjustment is needed for CYP3A
substrates or for drugs that are sensitive substrates of efflux and
hepatic uptake transporters when co-administrated with
bemnifosbuvir. CYP3A is an enzyme that metabolizes many classes of
prescribed medicines and medicinal supplements, and efflux/hepatic
uptake transporters regulate cellular trafficking of many drugs
that are commonly prescribed to patients that are at high risk for
severe COVID-19.
These results were presented at the Conference on Retroviruses
and Opportunistic Infections (CROI), which took place February
19-22, 2023 in Seattle, Washington.
Bemnifosbuvir is an investigational orally administered,
direct-acting antiviral. It is being evaluated in the global
SUNRISE-3 Phase 3 registrational trial for the treatment of
COVID-19 in non-hospitalized patients at high risk for disease
progression to hospitalization and death.
“A key limitation of currently available treatments for COVID-19
is drug-drug interactions, especially for elderly and
immunocompromised patients,” said Jean-Pierre Sommadossi, PhD,
Chief Executive Officer and Founder of Atea Pharmaceuticals. “We
are pleased that the clinical data presented at CROI demonstrate
that bemnifosbuvir may be co-administered without drug-drug
interactions with commonly prescribed therapeutics that patients
may be taking for other conditions. In the Phase 3 SUNRISE-3 trial,
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.”
Poster Number:
512Title: No Dose Adjustments for CYP3A4
Substrates When Co-Administered with Bemnifosbuvir
Results from a Phase 1, open-label, drug-drug interaction (DDI)
study suggest that no dose adjustments are needed when
bemnifosbuvir is co-administered with drugs that are substrates of
CYP3A4.
In the study, bemnifosbuvir was administered with midazolam
(MDZ; used as a sensitive CYP3A4 index drug) in 24 healthy
participants and was well tolerated. Results showed a single dose
(simultaneous or staggered) of bemnifosbuvir only slightly
increased the plasma exposure of MDZ. After repeat dosing of
bemnifosbuvir simultaneously administered with MDZ, bemnifosbuvir
increased plasma MDZ (less than twofold) without affecting the
exposure of the 1-hydroxymidazolam (1-OH-MDZ).
Poster Number:
513
Title: Bemnifosbuvir Has Low Potential to
Inhibit P-gp, BCRP and OATP1B1 Mediated Transport
Results from two Phase 1, open-label, drug-drug interaction
studies suggest bemnifosbuvir has low potential to exhibit
clinically meaningful inhibition of P-glycoprotein (P-gp) or breast
cancer resistance protein (BCRP)/organic anion transporter
polypeptide 1B1 (OATP1B1) drug transporters. Therefore, no dose
adjustment is expected for drugs that are sensitive substrates of
these transporters when co-administered with bemnifosbuvir.
The efflux transporters P-gp and BCRP and the hepatic uptake
transporter OATP1B1 regulate cellular trafficking of many drugs
that are commonly prescribed to patients that are at high risk for
severe COVID-19. These drugs include immunosuppressants, certain
antibiotics, statins and other cardiovascular medications, certain
diabetes medicines and chemotherapy.
The studies assessed the effect of bemnifosbuvir on digoxin
(DIG) and rosuvastatin (ROSU), which were used as P-gp and
BCRP/OATP1B1 index drugs, respectively.
Bemnifosbuvir administered with DIG or ROSU was well tolerated
in the 29 healthy participants that were included in each study. A
single high dose of bemnifosbuvir 1100 mg simultaneously
administered with DIG slightly increased the Cmax of DIG yet had no
effect on its AUC, which is consistent with the transient nature of
bemnifosbuvir plasma pharmacokinetics (PK). When dosed staggered,
bemnifosbuvir did not affect the PK of DIG. A single dose
(simultaneous or staggered) of bemnifosbuvir 1100 mg administered
with ROSU slightly increased the plasma exposure of ROSU.
About Bemnifosbuvir
for COVID-19Bemnifosbuvir, 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 chain
termination (RdRp) and nucleotityltransferase (NiRAN) inhibition,
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 or interest that have been
tested, including Omicron subvariants BA.4 and BA.5. Bemnifosbuvir
is currently being evaluated in SUNRISE-3, a global Phase 3
registrational study of bemnifosbuvir in high-risk non-hospitalized
patients with COVID-19.
About Atea PharmaceuticalsAtea 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,
hepatitis C virus (HCV) and dengue virus. For more information,
please visit www.ateapharma.com.
Forward-Looking StatementsThis 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,
the combination of bemnifosbuvir and ruzasvir for the potential
treatment of HCV and AT-752 for the potential treatment of dengue.
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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