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Chimerix Initiates Phase 3
SUPPRESS Trial of Brincidofovir (CMX001) for Prevention of CMV in HCT
Recipients
DURHAM, N.C., Sept. 9, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc.
(Nasdaq:CMRX), a biopharmaceutical company developing novel, oral
antivirals in areas of high unmet medical need, today announced
initiation of dosing in the Phase 3 SUPPRESS trial (ClinicalTrials.gov
ID: NCT01769170). SUPPRESS is evaluating brincidofovir (CMX001) for the
prevention of cytomegalovirus (CMV) infection, the most significant
infectious disease in hematopoietic cell transplant (HCT) recipients.
Brincidofovir is an investigational oral nucleotide analog
lipid-conjugate that has demonstrated activity against all pathogenic
double-stranded DNA (dsDNA) viruses, including herpesviruses,
adenoviruses, and polyomaviruses.
"Initiation of our Phase 3 SUPPRESS trial marks a significant milestone
in the development program for brincidofovir," said Kenneth I. Moch,
President and CEO of Chimerix. "A well-tolerated and effective
prevention for CMV disease in hematopoietic cell transplant patients
remains an important unmet medical need, as existing antiviral therapies
are limited by significant hematologic and renal toxicities."
SUPPRESS is designed to demonstrate the efficacy and safety of
brincidofovir for the prevention of CMV infection versus a placebo
control, as no therapy is currently approved for the prevention of CMV
in HCT recipients. The primary endpoint for SUPPRESS is prevention of
clinically significant CMV infection through the first 24 weeks
post-transplant. The trial is powered to detect a relative 50% decrease
in clinically significant CMV infection in subjects receiving
brincidofovir versus those receiving placebo. Secondary endpoints in the
SUPPRESS trial include evidence of other dsDNA viruses, including
adenovirus (AdV), varicellovirus (VZV), BK virus (BKV), and other
herpesviruses such as HHV-6, which contribute to morbidity and mortality
in the first year following HCT.
SUPPRESS is anticipated to enroll approximately 450 HCT recipients who
are at increased risk of CMV infection, with approximately 300 of the
450 enrolled subjects receiving twice weekly (BIW) brincidofovir versus
placebo (2-to-1 ratio). Dosing of study drug will begin shortly after
subjects receive their transplant, and will not require evidence of stem
cell "engraftment" (evidence of production of blood cells by the new
transplant), a safety precaution in the Phase 2 trial of brincidofovir
and other recent trials of investigational antivirals for CMV
prevention. The ability to begin prevention during the early
post-transplant period may decrease the risk of CMV infection in
transplant patients.
Subjects enrolled in SUPPRESS will receive brincidofovir or placebo from
the early post-transplant period through Week 14 post-transplant, the
period of highest risk for viral reactivation. Enrolled subjects will
continue to be monitored for evidence of CMV reactivation and other
dsDNA viral infections through Week 24 post-transplant. The recently
approved Roche TAQMAN® real-time polymerase chain reaction assay will be
used to monitor levels of CMV in the blood. Approximately 40 transplant
centers will participate in SUPPRESS.
Data from SUPPRESS are anticipated in 2015 and, if positive, may support
Accelerated Approval of brincidofovir for the prevention of CMV
infection.
"Initiation of patient dosing in SUPPRESS advances the development
program for brincidofovir, which has the potential to make a meaningful
difference in the lives of immunocompromised patients," said M. Michelle
Berrey, MD, MPH, Chief Medical Officer of Chimerix. "Because transplant
patients are too often faced with the clinical consequences of multiple
dsDNA viral infections, brincidofovir with its broad spectrum antiviral
activity has the potential to improve overall outcomes in patients
undergoing HCT, through both direct and indirect effects of prevention
of CMV and other dsDNA viral infections."
In addition to the ongoing Phase 3 SUPPRESS trial, Chimerix has recently
announced top line data from a Phase 2 trial of brincidofovir for AdV
infection in pediatric and high-risk adult HCT recipients. Results from
this trial will be presented as a late-breaker at the annual ICAAC
Conference on September 10, 2013.
About Brincidofovir (CMX001)
Brincidofovir is an investigational oral nucleotide analog
lipid-conjugate that has shown broad-spectrum antiviral activity against
all five families of dsDNA viruses that affect humans, including
herpesviruses such as CMV, adenoviruses, polyomaviruses such as BKV,
papillomaviruses, and orthopoxviruses. In a Phase 2 trial of 230 HCT
recipients, brincidofovir demonstrated potential clinical utility in
prevention of CMV infection. In this same CMV trial,
brincidofovir-treated subjects had improvements in kidney function and
hematuria (blood in the urine) when compared to placebo-treated
subjects, suggesting that brincidofovir may reduce BKV-associated
bladder and renal damage. In September 2013, Chimerix initiated the
Phase 3 SUPPRESS trial for the prevention of CMV in HCT recipients.
Chimerix recently announced top line data from its Phase 2 trial in
pediatric and adult HCT recipients evaluating brincidofovir as a
preemptive therapy for AdV disease, an often fatal infection with no
approved therapies. These data, which will be presented at the annual
ICAAC conference, support continued development of brincidofovir as a
broad-spectrum antiviral therapy for CMV and AdV. Brincidofovir has a
favorable safety and tolerability profile, with no evidence of kidney or
bone marrow toxicity in over 900 patients dosed with brincidofovir for
prevention, preemptive therapy, or treatment of dsDNA viruses that cause
disease in humans.
About Cytomegalovirus (CMV) and Double-Stranded DNA (dsDNA)
Viruses
CMV is a member of the herpesvirus family and the most common infectious
pathogen in transplant recipients. A majority of adults in the US have
been exposed to CMV, generally in childhood, with lifelong viral latency
established following resolution. In healthy individuals with a
functioning immune system, CMV remains dormant throughout life. A
functioning immune system protects an infected individual against future
exposure to CMV but does not clear the virus from their body. In
immunocompromised individuals with weakened immune systems, such as
transplant recipients, CMV often reactivates during the post-transplant
period when the immune system is rebuilding itself. No therapies are
approved for the prevention of CMV in HCT recipients. Currently
available systemic anti-CMV agents can be effective against CMV;
however, their use is limited by significant toxicities, including bone
marrow suppression and renal impairment, and these therapies are only
approved for certain solid organ transplant patient populations. CMV
infection is known to correlate with progression to CMV disease and
death. CMV itself is immunosuppressive and reactivation of the virus can
predispose a patient to other opportunistic viral infections in addition
to fungal and bacterial infections.
About Hematopoietic Cell Transplantation (HCT)
HCT is a medical procedure performed most frequently for hematology and
oncology indications to treat patients with certain cancers of the blood
and bone marrow, such as multiple myeloma or leukemia, or genetic
diseases. For these patients, replacement of the blood forming system is
the best therapeutic alternative. Because of chemotherapy and
immunosuppressants that are used before, during and after the procedure,
patients are highly susceptible to viral, bacterial and fungal
infections and associated complications related to the chemotherapy and
immunosuppression. These post-transplant complications are a significant
cause of morbidities and mortalities following the procedure.
About Chimerix
Chimerix, a biopharmaceutical company based in Durham, NC, is committed
to the discovery, development and commercialization of novel, oral
antiviral therapeutics designed to transform patient care in areas of
high unmet medical need. Chimerix's proprietary lipid technology has
given rise to two clinical-stage nucleotide analog lipid-conjugates,
brincidofovir (CMX001) and CMX157, which have demonstrated the potential
for enhanced activity and safety in convenient, orally administered
dosing regimens. Brincidofovir has shown broad-spectrum activity against
dsDNA viruses, including herpesviruses, adenoviruses and polyomaviruses.
Chimerix's second product candidate, CMX157, an oral nucleotide analog
for the treatment of HIV infection, was licensed to Merck in July 2012.
Forward-Looking Statements
Statements contained in this press release regarding matters that are
not historical facts are "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding Chimerix's Phase 3 SUPPRESS trial, the efficacy
of brincidofovir and its ability to provide a broad spectrum of
antiviral activity and the positive impact of brincidofovir on
transplant recipients. Risks that contribute to the uncertain nature of
the forward-looking statements include: the success of SUPPRESS; the
demonstrated efficacy of brincidofovir in the SUPPRESS trial; and
regulatory developments in the United States and foreign countries.
Other risks and uncertainties affecting Chimerix are described more
fully in Chimerix's filings with the Securities and Exchange Commission,
including without limitation its most recent Quarterly Report on Form
10-Q, its most recently filed reports on Form 8-K 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. Chimerix
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
Chimerix Contact:
Joseph T. Schepers
Executive Director, Investor Relations
919-287-4125
Media Contact:
Tony Plohoros
tplohoros @6degreespr.com
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