CARLSBAD, Calif., Oct. 30, 2015 /PRNewswire/ -- Isis
Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a
Phase 2 study evaluating ISIS-FXIRx in patients with
end-stage renal disease (ESRD) on hemodialysis. In
May 2015, Isis entered into an
exclusive license agreement with Bayer HealthCare (Bayer) to
develop and commercialize ISIS-FXIRx for the prevention
of clotting disorders. The Phase 2 study is intended to further
characterize the profile of ISIS-FXIRx and will provide
essential data for Bayer's future clinical development program for
ISIS-FXIRx. Upon completion of the study and advancement
of the program by Bayer, Isis will be eligible to receive a
$55 million payment.
"ESRD patients receiving chronic dialysis are prone to increased
thrombosis. However, antithrombotic treatment options for these
patients remain limited because these patients also have a high
risk of bleeding. ISIS-FXIRx is a first-in-class
antisense drug in clinical development that has shown a significant
reduction in clotting without increasing bleeding events in
previous clinical studies. This Phase 2 study furthers both our and
Bayer's goal of initially providing ISIS-FXIRx to
patients with high unmet need," said B.
Lynne Parshall, chief operating officer at Isis
Pharmaceuticals. "These data will support Bayer's plans for a
robust development program to optimize the clinical potential of
this drug."
ISIS-FXIRx is designed to inhibit the production of
Factor XI, a coagulation factor produced in the liver that is
involved in the propagation of clots. The Phase 2 study is a
randomized, double-blind, placebo controlled study in which
ISIS-FXIRx will be administered to approximately 50
patients with ESRD on hemodialysis. The first patient has already
been dosed in this study that will evaluate the safety,
pharmacokinetic and pharmacodynamic effects of weekly dosing of
200mg or 300mg ISIS-FXIRx for up to 12 weeks.
ABOUT ISIS-FXIRx
ISIS-FXIRx is an antisense drug in development for
the prevention of clotting disorders. High levels of Factor XI
increase the risk of thrombosis, a process involving aberrant blood
clot formation that can be responsible for heart attacks and
strokes, while Factor XI deficiency results in a lower incidence of
thromboembolic events with minimal increase in bleeding risk. In a
Phase 2 comparator-controlled study evaluating the incidence of
venous thromboembolic events, or VTEs, in patients treated with
ISIS-FXIRx undergoing total knee replacement surgery,
patients treated with 300mg of ISIS-FXIRx experienced a
seven-fold lower rate of VTE as compared with those treated with
enoxaparin (4.2% and 30.4%, respectively; p<0.001). In this
study, ISIS-FXIRx was generally well tolerated with no
observed differences in safety outcomes compared with enoxaparin.
The data from this study was published in the New England Journal
of Medicine in December 2014.
ABOUT ISIS' LICENSE AGREEMENT WITH BAYER
Isis and Bayer entered into an exclusive license agreement to
develop and commercialize ISIS-FXIRx for the prevention
of clotting disorders. After completion of ongoing activities at
Isis, Bayer will assume all global clinical development as well as
worldwide regulatory and commercialization responsibilities for
ISIS-FXIRx. As part of the clinical development program,
Bayer plans to evaluate the therapeutic profile of
ISIS-FXIRx in patients for whom currently available
anticoagulants may not be used, such as in patients with a high
risk of bleeding due to multiple co-morbidities. Isis is eligible
to receive milestone payments as the drug advances toward the
market and is eligible to receive tiered royalties in the low to
high twenty percent range on gross margins of
ISIS-FXIRx.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is the leading company in RNA-targeted drug discovery and
development focused on developing drugs for patients who have the
highest unmet medical needs, such as those patients with severe and
rare diseases. Using its proprietary antisense technology,
Isis has created a large pipeline of first-in-class or
best-in-class drugs, with over a dozen drugs in mid- to late-stage
development. Drugs currently in Phase 3 development include
volanesorsen, a drug Isis is developing and plans to commercialize
through its wholly owned subsidiary, Akcea Therapeutics, to treat
patients with familial chylomicronemia syndrome and familial
partial lipodystrophy; ISIS-TTRRx, a drug Isis is
developing with GSK to treat patients with all forms of TTR
amyloidosis; and ISIS-SMNRx, a drug Isis is developing
with Biogen to treat infants and children with spinal muscular
atrophy. Isis' patents provide strong and extensive
protection for its drugs and technology. Additional
information about Isis is available at www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding
Isis' alliance with Bayer, the development, activity, therapeutic
and commercial potential and safety of ISIS-FXIRx. Any
statement describing Isis' goals, expectations, financial or other
projections, intentions or beliefs is a forward-looking statement
and should be considered an at-risk statement. Such
statements are subject to certain risks and uncertainties,
particularly those inherent in the process of discovering,
developing and commercializing drugs that are safe and effective
for use as human therapeutics, and in the endeavor of building a
business around such drugs. Isis' forward-looking statements
also involve assumptions that, if they never materialize or prove
correct, could cause its results to differ materially from those
expressed or implied by such forward-looking statements.
Although Isis' forward-looking statements reflect the good faith
judgment of its management, these statements are based only on
facts and factors currently known by Isis. As a result, you
are cautioned not to rely on these forward-looking
statements. These and other risks concerning Isis' programs
are described in additional detail in Isis' annual report on Form
10-K for the year ended December 31,
2014, and its most recent quarterly report on Form 10-Q,
which are on file with the SEC. Copies of these and other
documents are available from the Company.
In this press release, unless the context requires otherwise,
"Isis," "Company," "we," "our," and "us" refers to Isis
Pharmaceuticals and its subsidiaries.
Isis Pharmaceuticals® is a registered trademark of
Isis Pharmaceuticals, Inc. Akcea Therapeutics™ is a trademark
of Isis Pharmaceuticals, Inc.
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SOURCE Isis Pharmaceuticals, Inc.