DURHAM, N.C., Nov. 17, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company discovering and developing medicines that improve outcomes for immunocompromised patients, presented data from a preclinical study of intravenous (IV) brincidofovir to determine tissue distribution after single IV or oral administration of the drug. These data were presented at the American Association of Pharmaceutical Scientists’ Annual Meeting in Denver, Colorado.
Data from this study showed that oral administration of brincidofovir provided consistent drug exposure to organs that are often the target of viral infection, such as the liver and kidney, but delivered much higher drug exposures in the small intestine than in other anatomical sites. In contrast, the new intravenous formulation of brincidofovir demonstrated much lower, yet constant exposure levels to the small intestines. The IV formulation delivered more uniform drug exposure levels to key organs including the small intestine, liver and kidney. Importantly, IV administration of brincidofovir resulted in higher central nervous system concentrations, which may support testing of this formulation in viral infections in the brain.
“Data from this study demonstrate limited gastrointestinal exposure with the intravenous formulation of brincidofovir,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “Clinical studies of this formulation will allow us to determine if the gastrointestinal side-effects observed in prior studies of oral brincidofovir can now be addressed, while maintaining antiviral efficacy.”
As the new IV formulation of brincidofovir progresses in clinical studies, brincidofovir remains in development as an orally-administered lipid conjugate nucleotide for the treatment of adenovirus in hematopoietic cell transplant recipients and other immunocompromised patients, and as a medical countermeasure for the treatment of smallpox.
Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date. Brincidofovir has received Fast Track designation from the FDA for adenovirus, cytomegalovirus (CMV) and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus and for the prevention of CMV disease, and the Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for an Orphan Designation for the treatment of smallpox.
Chimerix is a biopharmaceutical company dedicated to discovering and developing medicines that improve outcomes for immunocompromised patients. Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals in 2014; and earlier-stage clinical candidates. Chimerix recently announced a new clinical candidate, CMX521, for the treatment and/or prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT:
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