- Pivotal AdAPT Study of Oral Brincidofovir for
Adenovirus Now Enrolling -
Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing
novel antivirals for the growing population of immunocompromised
patients, today provided an update on multiple clinical development
programs including oral brincidofovir (BCV), intravenous (IV) BCV,
and CMX521.
“We are especially pleased to begin 2018 with the initiation of
AdAPT, a comparative study designed together with European
regulators to demonstrate the superiority of brincidofovir’s
antiviral effect in pediatric transplant recipients facing
life-threatening adenovirus infection. As we’ve seen in multiple
other settings, clearance of adenovirus has a positive impact on
survival in the first year after transplant. Positive data from
AdAPT is expected to provide the basis for a European marketing
approval, and if clinical benefits are confirmed, could be
considered for an accelerated approval under the FDA’s Subpart H
guidance. Our team is committed to fulfilling the promise of
brincidofovir and its potential as the first approved antiviral for
adenovirus infections,” stated M. Michelle Berrey, MD, MPH,
President and Chief Executive Officer of Chimerix.
“We are also happy to report successful
administration of 2-4 weeks of IV BCV without dose-limiting
gastrointestinal events, supporting the progression to Phase 2
studies of IV BCV in virally infected transplant recipients.
Specifically, twice-weekly doses of IV BCV 10 mg provide similar
blood levels of the drug as the oral BCV 100 mg dose previously
studied in late-stage trials, but did not result in any reported
diarrhea. Proposals for these Phase 2 studies of IV BCV in
virally-infected patients are currently being reviewed by
regulators in Europe, and are expected to provide data later in the
year.”
“And finally, our new molecule, CMX521, is the
first direct-acting antiviral for norovirus to progress to
clinical-stage development. We look forward to sharing more on this
compound as we complete initial clinical assessments,” concluded
Dr. Berrey.
Initiation of AdAPT Study of Oral
Brincidofovir in Adenovirus
The Company reports the initiation of the AdAPT Study
(Adenovirus after Allogeneic Pediatric Transplantation). This study
is targeting enrollment of 141 pediatric allogeneic hematopoietic
stem cell transplant (HCT) recipients with confirmed adenovirus
(AdV) infection; patients will be randomized 2:1 to receive
short-course oral BCV or local standard-of-care (SOC) treatment at
approximately 30 sites in Europe and the United States.
The primary endpoint of the study is a
comparison of the average adenovirus viral burden (as measured by
AdV DNA levels in blood) over 16 weeks in subjects treated with
short-course oral BCV versus those who receive local SOC. The study
is 90% powered to show the superiority of reduced adenoviral burden
in brincidofovir-treated patients compared to SOC. The study will
also evaluate the correlation of AdV burden (and its clearance)
with clinical outcomes including survival. Enrollment is estimated
to complete in 2019.
IV Brincidofovir Progresses to Phase 2
Studies
The Company announces the successful completion
of the multiple ascending dose (MAD) study of IV BCV in healthy
subjects. This study evaluated the safety, tolerability and
pharmacokinetics of IV BCV 10 mg given twice weekly and IV BCV 20
mg given once weekly in healthy subjects for two to four weeks. IV
BCV was well-tolerated at all dose levels, with no dose-limiting
clinical adverse events. Importantly, there was no diarrhea
reported for IV BCV 10 mg dosed twice weekly, a dose that provides
drug levels equivalent to oral BCV 100 mg which demonstrated
antiviral activity in previous late-stage clinical studies.
Proposals for studies of IV BCV in virally-infected patients have
progressed to regulatory review in Europe and are expected to
provide data in the second half of 2018.
Preparation Underway for European
Regulatory Submission for Smallpox
In late November, the Company received advice
from the European Medicines Agency (EMA) on the development plan
for smallpox, in which the submission of a marketing application
with data from completed studies, including the large rabbitpox
efficacy study, VIR-041, was discussed. This rabbitpox study, as
previously reported, demonstrated 100% survival in animals with
confirmed viral infection treated with BCV, a clinically and
statistically significant improvement compared with <50%
survival in animals that received placebo. This study in
combination with supportive mousepox study data was considered
sufficient for review by EMA. The Company is in the process of
preparing for a marketing application submission to EMA in early
2019. Chimerix intends to submit a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA), contingent upon
the results of animal efficacy studies to be conducted in
2018.
CMX521 for Norovirus
Chimerix announces the initiation of its
first-time-in-human study of CMX521, a nucleoside analog identified
from the Chimerix Chemical Library, as a potential treatment
and/or prevention for norovirus. The Phase 1 study will evaluate
the pharmacokinetics, safety and tolerability of CMX521 in up to 50
adult subjects. The study also includes the collection of gut
biopsy specimens, which will allow determination of active drug
concentrations in the target gut tissue. Study results are expected
in
mid-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 the herpesviruses and adenoviruses. 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 adenovirus, cytomegalovirus (CMV) and
smallpox. Brincidofovir has also received Orphan Medicinal Product
Designation from the European Commission for adenovirus, CMV, and
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 a new clinical
candidate, CMX521, the first direct-acting antiviral specifically
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 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. 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) 972-7115 ir@chimerix.com or Will O’Connor Stern
Investor Relations Will@sternir.com 212-362-1200
Media: Becky VonsiatskyW2O
Groupbvonsiatsky@w2ogroup.com413-478-2003
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