Atea Pharmaceuticals Reports Nonclinical Bemnifosbuvir (AT-527) Toxicology Data at Society of Toxicology 61st Annual Meeting
March 28 2022 - 7:00AM
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a
clinical-stage biopharmaceutical company, today presented two
posters highlighting nonclinical data demonstrating the nonclinical
safety of bemnifosbuvir (AT-527) at the Society of Toxicology (SOT)
61st Annual Meeting taking place in San Diego, California from
March 27 – 31, 2022. Atea’s poster board presentation P857 was
selected by the SOT Risk Assessment Specialty Selection Executive
Committee as a top ten abstract this year.
“We are very pleased with the favorable nonclinical toxicity
profile for bemnifosbuvir as evidenced by the results of the
studies presented today,” said Jean-Pierre Sommadossi, Ph.D., Chief
Executive Officer and Founder of Atea Pharmaceuticals. “We believe
the favorable toxicity profile of bemnifosbuvir makes it ideal for
clinical development in broad patient populations and in oral
combination regimens for the treatment of severe viral infections,
such as COVID-19 and hepatitis C.”
The following poster boards highlighting the favorable
bemnifosbuvir nonclinical safety assessment and toxicology data
were presented:
Abstract 4793/Poster Board
P857: Lack of Reproductive and Developmental Toxicity for AT-527,
an Oral Purine Nucleotide Prodrug for COVID-19 Infection
presented by Shouqi Luo, Ph.D., Executive Director of Toxicology at
Atea and authored by Dr. Luo and other Atea scientists.
- Highlights of the data showed that:
- There were no AT-527-related effects on the fertility,
reproduction, embryofetal and postnatal development in rats.
- In rabbits, there were no AT-527-related embryofetal
abnormalities at doses up to 100 mg/kg/day even in the presence of
evident maternal toxicities at 100 mg/kg/day, i.e., body weight
loss, abortions, and mortalities, which were secondary to reduced
food consumption.
- The maternal toxicity of AT-527 in rabbits was confounded by
the vehicle which itself resulted in reduced food consumption and
body weight loss noted in a 7-day tolerability study in nonpregnant
female rabbits.
Abstract 4794/Poster Board
P858: Characterization of the Toxicity Profile of AT-527, a Novel
Guanosine Nucleotide Prodrug with Antiviral Activity for COVID-19
Infection presented by Steven Good, Executive Vice
President, Preclinical Science at Atea, and authored by other Atea
scientists.
- Highlights of the data showed that:
- AT-527 exhibited low potential for QTc prolongation in rats and
monkeys.
- AT-527 and its metabolites were negative in a battery of in
vitro and in vivo genetic toxicity assays.
- In repeat dose oral toxicity studies in rats and monkeys up to
13 weeks, no target organ toxicity was identified.
- Dose-related reversible liver weight increases were noted in
rats with correlating hepatocellular hypertrophy in the rat 13-week
study. These changes were considered adaptive.
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. 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, 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 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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