Chimerix Presents Data from a Preclinical Study of Intravenous Brincidofovir at AAPS
November 17 2016 - 8:00AM
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.
About Brincidofovir
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.
About Chimerix
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.
Forward-Looking Statements
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:
Investor Relations:
ir@chimerix.com
or
Will O’Connor
Stern Investor Relations
Will@sternir.com
212-362-1200
Media:
Becky Vonsiatsky
W2O Group
bvonsiatsky@w2ogroup.com
413-478-2003
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Apr 2023 to Apr 2024