“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
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
- 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
- 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.
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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
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