Chimerix, in Collaboration with the Rapidly Emerging Antiviral Drug Development Initiative (READDI) at the University of North Carolina-Chapel Hill, Announces Late-Breaking Oral Presentation at International Conference on Antiviral Research
“While we focus on the advancement of our oncology pipeline and progress toward a TEMBEXA procurement agreement with BARDA, this collaboration with READDI allows us to efficiently evaluate our antiviral library to identify molecules that might have value to patients,” said
“These compelling data encourage us to further investigate the potential of CMX521 as a prophylactic and as a therapeutic for SARS-CoV-2 infection,” said
The presentation is titled, “The nucleoside analog antiviral CMX521 inhibits SARS-CoV-2 in human airway epithelial cell cultures and exhibits prophylactic and therapeutic efficacy against respiratory disease in a mouse model of SARS-CoV-2 infection”, highlights in vitro activity and in vivo efficacy of this novel compound. In vitro, CMX521 was shown to inhibit SARS-CoV-2 replication in primary human airway epithelial cells with an average EC50 of 0.9µM. In vivo, studies were performed in an animal model used during development of a different antiviral therapy which has obtained Emergency Use Authorization for SARS-CoV-2 in
Monotherapy prophylactic administration of aerosol CMX521 every eight hours starting eight hours prior to infection reduced average viral titers in lung on day four post-infection by 3.62 log10 (>99.9% reduction) and prevented weight loss/clinical progression versus placebo. Antiviral efficacy was also demonstrated with monotherapy treatment when CMX521 was initiated post-infection. CMX521 treatment significantly reduced SARS-CoV-2 in the lung (Kruskal-Wallis p<0.0001) and protected mice from clinical symptoms of disease including weight loss and adverse lung pathology (p<0.0001) at day four post-infection relative to placebo.
CMX521 is not mutagenic, clastogenic, or associated with mitochondrial toxicity. In addition, oral CMX521 demonstrated a favorable profile in GLP toxicology studies and was well-tolerated up to 2,400 mg in a healthy volunteer Phase 1 study for a different indication.
Rapidly Emerging Antiviral Drug Development Initiative is a global public-private partnership founded at the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the results of current and future preclinical and clinical testing of CMX521. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the current and future preclinical and clinical study data for CMX521 will not generate positive results or may not support accelerated, or any, regulatory approval; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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Source: Chimerix, Inc.