Study confirms drug levels for IV BCV 10 mg equivalent to oral BCV 100 mg
No gastrointestinal side effects seen with IV BCV at 10 and 25 mg doses
In this ongoing study, IV administration of BCV demonstrated a favorable tolerability profile at both doses tested to date. No drug related adverse events (AEs) or laboratory abnormalities were identified. Notably, gastrointestinal (GI) side effects were absent. Blood plasma concentrations of BCV which have previously demonstrated anti-viral potency in cytomegalovirus (CMV) prevention and adenovirus treatment were achieved with IV doses that were one tenth of those required with oral dosing. This suggests that even the lowest tested IV dose of brincidofovir should provide antiviral activity.
"Data from this ongoing study suggest that brincidofovir was generally safe and well tolerated at the 10 and 25 mg doses, and achieved target plasma concentrations," said M.
A total of 40 healthy subjects will be randomized to receive either a single dose of IV BCV or IV placebo in one of four cohorts. To date, 16 subjects have enrolled into 2 dose groups; 8 subjects were randomized in each of Cohorts 1 (IV BCV 10 mg) and 2 (IV BCV 25 mg). It is anticipated that two additional cohorts will be enrolled.
As the new IV formulation of BCV progresses in clinical studies, BCV 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.
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 BCV, that any clinical trials we may conduct will not demonstrate adequate efficacy and safety of BCV, that enrollment in clinical trials we may conduct may be insufficient or slower than we anticipate,
that the FDA and other regulatory authorities may not approve BCV or BCV-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, BCV may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for BCV 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
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