Broad-spectrum antiviral Brincidofovir has shown favorable tolerability in its intravenous formulation, according to preclinical data presented by Chimerix at the American Association of Pharmaceutical Scientists‘ Annual Meeting.
Brincidofovir has received Fast Track designation from the FDA for adenovirus, cytomegalovirus (CMV) and smallpox.
Data from the preclinical 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 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.