AMAG Announces Presentation of Ciraparantag Data at the International Society on Thrombosis and Haemostasis
12 Juli 2020 - 2:30PM
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the
poster presentation of data from two Phase 2 randomized,
placebo-controlled, dose ranging studies which showed safety and
efficacy of ciraparantag reversing the effects of apixaban and
rivaroxaban in healthy adults age 50-75 years. The poster,
“Efficacy and Safety of Ciraparantag in Reversing Apixaban and
Rivaroxaban in Healthy Adults” was accepted for the 2020
International Society on Thrombosis and Haemostasis (ISTH) virtual
annual meeting. Ciraparantag is in development for use in patients
treated with direct oral anticoagulants (DOACs) and low molecular
weight heparin (LMWH) when reversal of the anticoagulant effect of
these products is needed for emergency surgery, urgent procedures
or due to life-threatening or uncontrolled bleeding.
Results from both studies, which randomized a total of 113
subjects, showed that steady-state anticoagulation induced by
apixaban or rivaroxaban was reversed by a single IV infusion of
ciraparantag in a dose-related manner as assessed by whole blood
clotting time (WBCT). WBCT is a direct measure of
anticoagulation/hemostasis and a global measure of clotting. Mean
WBCT values in the ciraparantag groups decreased toward baseline 15
minutes after dosing, versus placebo which took five hours
commensurate with the decline of anticoagulant drug concentration.
For reversal, defined as achieving a WBCT ≤10% above baseline
within one hour after dosing and subsequently sustained through at
least five hours, this response was achieved in 100 percent of
subjects receiving ciraparantag doses ≥60 mg for reversal of
apixaban, and 100 percent of subjects receiving ciraparantag doses
of 180 mg for reversal of rivaroxaban. Ciraparantag was well
tolerated at all doses evaluated in these studies. The most
frequent adverse events associated with ciraparantag were mild,
transient sensations of warmth or flushing, which were observed
more frequently with higher doses of ciraparantag.
“DOACs have become the dominant means for chronic
anticoagulation, and there remains a need for an effective reversal
agent with broad activity that can be administered quickly and
conveniently for patients with serious uncontrolled bleeding or
those who require emergency surgery,” said Dr. Jack Ansell,
Professor of Medicine, Hofstra Northwell School of Medicine. “These
data are encouraging as they demonstrate a ciraparantag dose
response for reversal of apixaban and rivaroxaban which, along with
the safety findings, will inform dose selection for future
studies.”
In the two studies, adult subjects were treated with apixaban or
rivaroxaban and those who reached steady-state anticoagulation were
randomized within each dose cohort in a 3:1 ratio to receive
ciraparantag or placebo, which was administered three or four hours
after last dose of the anticoagulant. Ciraparantag was administered
as a single intravenous infusion over 10 minutes, followed by
serial testing of WBCT over 24 hours. Doses of ciraparantag were
evaluated at 30 mg, 60 mg and 120 mg for apixaban and 30 mg, 60 mg,
120 mg and 180 mg for rivaroxaban.
About CiraparantagCiraparantag is a
novel small, water-soluble molecule being investigated for reversal
of anticoagulation induced by direct oral anticoagulants (DOACs) or
low molecular weight heparin (LMWH). Target patient populations
include patients for whom rapid reversal of anticoagulation is
needed because of life-threatening or uncontrolled bleeding, or for
emergency surgery or urgent procedures. It is believed
that ciraparantag exerts its effects by binding
to and blocking the effects of DOACs such as Xarelto®
(rivaroxaban), Eliquis® (apixaban) and Savaysa® (edoxaban), as well
as to the LMWH Lovenox® (enoxaparin sodium injection), which
in turn reestablishes normal clot formation. Ciraparantag is
administered by intravenous infusion; the anticipated clinical
treatment regimen is a single dose administered over approximately
10 minutes. Ciraparantag has been studied across seven
completed trials, with 277 subjects having been dosed with
ciraparantag and has been well tolerated in these studies. To date,
the most common adverse events related
to ciraparantag have been mild transient sensations of
warmth or skin flushing, skin tingling, and alterations in
taste.
ABOUT AMAG AMAG is a commercial stage
biopharmaceutical company focused on bringing innovative products
to patients with unmet medical needs. The company does this by
leveraging its development and commercial expertise to invest in
and grow its pharmaceutical products across a range of therapeutic
areas. For additional company information, please
visit www.amagpharma.com.
Forward Looking StatementsThis press release
contains forward-looking information about AMAG Pharmaceuticals,
Inc. within the meaning of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Any statements
contained herein which do not describe historical facts, including,
among others, AMAG’s beliefs about the mechanism of action of
ciraparantag and statements about ciraparantag, including the
safety and efficacy, anticipated target patient population and
dosing regimen for ciraparantag are based on management’s current
expectations and beliefs and are forward-looking statements which
involve risks and uncertainties that could cause actual results to
differ materially from those discussed in such forward-looking
statements.
Such risks and uncertainties include, among others, the risk
that ciraparantag is not approved as a reversal agent for a broad
spectrum of anticoagulants, as well as those risks identified in
AMAG’s filings with the U.S. Securities and Exchange Commission
(SEC), including its Annual Report on Form 10-K for the year ended
December 31, 2019, its Current Reports on Form 8-K, its Quarterly
Reports on Form 10-Q, including for the quarter ended March 31,
2020, and in any subsequent filings with the SEC , which are
available at the SEC’s website at www.sec.gov. Any such risks and
uncertainties could materially and adversely affect AMAG’s results
of operations, its profitability and its cash flows, which would,
in turn, have a significant and adverse impact on AMAG’s stock
price. AMAG cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made.
AMAG disclaims any obligation to publicly update or revise any
such statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals®, the logo and designs, are registered
trademarks of AMAG Pharmaceuticals, Inc. Any other trademarks
referred to in this report are the property of their respective
owners.
AMAG CONTACTS:Investors: Loraine
Spreen617-866-0303
Media: Stacy Nartker(781) 430-9212
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