Chimerix Announces Preliminary Data from Ongoing Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subje...
January 06 2017 - 7:00AM
Study confirms drug levels for IV BCV 10 mg
equivalent to oral BCV 100 mg
Chimerix (NASDAQ:CMRX), a biopharmaceutical company discovering,
developing and commercializing medicines that improve outcomes for
immunocompromised patients, announced preliminary data from an
ongoing Phase 1 study to investigate the safety, tolerability and
plasma/intracellular concentration of intravenous (IV)
brincidofovir (BCV) following single escalating doses in healthy
adult subjects.
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. Michelle
Berrey, MD, MPH, President and CEO of Chimerix. “These
preliminary results build on our preclinical studies which showed
that IV brincidofovir was associated with fewer GI side effects. We
believe that IV brincidofovir represents a promising
investigational option for the prevention and treatment of a broad
range of life-threatening viral infections in immunocompromised
patients.”
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.
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. BCV has not
been associated with kidney or bone marrow toxicity in over 1,000
patients treated to date. BCV has received Fast Track designation
from the FDA for adenovirus, CMV and smallpox. BCV 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 has issued a positive opinion for an Orphan Designation
for the treatment of smallpox.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to
discovering, developing and commercializing medicines that improve
outcomes for immunocompromised patients. Chimerix's proprietary
lipid conjugate technology has produced BCV; CMX157, which was
licensed to ContraVir Pharmaceuticals; 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 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 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
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