Chimerix Presents Results from Multiple Ascending Dose Study of IV Brincidofovir at IDWeek
October 05 2018 - 7:00AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing
novel antivirals to address unmet medical needs, today announced
data from the company’s Phase 1 study evaluating the safety and
pharmacokinetics (PK) of multiple ascending doses (MAD) of
intravenous (IV) brincidofovir (BCV) in healthy subjects. These
data will be presented at IDWeek™ 2018, held October 3-7 in San
Francisco, CA.
“This study shows that four weekly or
twice-weekly doses of the IV formulation of brincidofovir are
generally well tolerated, and the 10 mg dose provides similar blood
levels as the oral 100 mg dose with no reported gastrointestinal
side effects,” said Garrett Nichols, MD, MS, Chief Medical Officer
of Chimerix. “We have now opened two additional studies in stem
cell transplant recipients in the U.S. and EU to confirm these
promising results.”
The Phase 1 study evaluated the safety and
pharmacokinetics of IV BCV in 27 healthy individuals who were
randomized 3:1 to receive IV BCV or placebo in sequential MAD
cohorts. Individuals receiving IV BCV were given a 10 mg dose in a
two-hour infusion twice a week for two weeks or a 20 mg dose in
either a one- or two-hour infusion once a week for four weeks.
Twice weekly doses of IV BCV at 10 mg provided similar blood levels
of the drug as the oral BCV 100 mg dose previously studied in
late-stage clinical trials, with no reported diarrhea or other
gastrointestinal adverse events.
Other key findings include:
- Both doses of IV BCV were generally safe and well
tolerated.
- No serious adverse events were reported; mild adverse events
with 10 mg dose included headache and bruising at IV site of
injection.
- Brincidofovir exposure was dose-proportional and no
accumulation was observed.
- Mild alanine aminotransferase (ALT) increases were reversible
upon cessation of drug, and were not associated with
hyperbilirubinemia, as seen with oral BCV.
Poster Presentation
Details:
- Abstract Title: IV Brincidofovir (BCV):
Pharmacokinetics (PK) and Safety of Multiple Ascending Doses (MAD)
in Healthy Subjects (1421)
- Session: Poster Abstract Session: PK/PD
Studies
- Location & Time: S Poster Hall; Friday,
October 5, 2018
About Brincidofovir
Chimerix's lead product candidate,
brincidofovir, is a nucleotide analog that has antiviral activity
against all five families of DNA viruses that affect humans,
including adenoviruses and variola virus, the virus that causes
smallpox. Brincidofovir has a high barrier to resistance, no
myelosuppression and a low risk of nephrotoxicity. Brincidofovir
has received Fast Track designation from the FDA for
cytomegalovirus (CMV) and smallpox. Brincidofovir has also received
Orphan Medicinal Product Designation from the European
Commission for the treatment of adenovirus, for the prevention
of CMV disease, and for the treatment of smallpox, and Orphan Drug
Designation from the FDA 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 and compound library have
produced brincidofovir (BCV, CMX001); CMX157, which was licensed to
ContraVir Pharmaceuticals; and CMX521, the first clinical-stage
direct-acting antiviral for the treatment and 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 our current or future
clinical trials of brincidofovir may not be successful, 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. Similar risks and uncertainties apply to
the Company’s development of CMX521. 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 press release 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: Michelle
LaSpaluto(919) 972-7115ir@chimerix.com or Will O’Connor Stern
Investor Relations Will@sternir.com 212-362-1200
Media: Laurie MasonsonW2O Grouplmasonson@w2group.com(917)
459-6164
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