Regado Biosciences Reports Clinical Results for REG1 Anticoagulation System at European...

Regado Biosciences Reports Clinical Results for REG1 Anticoagulation System at
European Society of Cardiology Congress 2008
Comprehensive Data Provide Initial Proof of Concept Across Multiple
Applications in the Hospital Setting

MUNICH, Germany, Sept. 2 /PRNewswire/ -- Regado Biosciences, Inc.
announced today the presentation of comprehensive results from Phase Ia, Ib
and Ic studies of the Company's REG1 Anticoagulation System at the European
Society of Cardiology's Congress 2008, currently being held in Munich,
Germany. REG1 is a two-component system composed of an aptamer-based
anticoagulant, RB006, and its matched, active reversal agent, RB007, which
binds to and neutralizes RB006.
Results from the three Phase I studies showed RB006 inhibited the activity
of factor IXa, a protein essential to blood clotting, and RB007 rapidly,
safely and specifically reversed the activity of RB006. Results from the
Phase Ic study further support the potential for RB007 to reverse the
anticoagulant effect of RB006 in a graded fashion either completely or
partially, depending on the dose of RB007. Detailed findings included:
-- Escalating doses of RB006 achieved a dose-dependent increase in
pharmacodynamic activity in healthy subjects, prolonging the activated
partial thromboplastin time (aPTT), a measure of the blood's ability to
clot.

-- This response also was seen in patients with stable coronary artery
disease, thereby confirming pharmacodynamic reproducibility in the
target patient population.

-- Escalating doses of RB007 rapidly achieved a dose-dependent decrease in
aPTT in patients previously dosed with RB006. Complete inhibition of
RB006 was shown within 1-5 minutes of administration of sufficient
doses of RB007.

-- No major bleeding, allergic or thrombotic events occurred in any of the
studies. The majority of events were minor bleeds at the venous access
site. The incidence of additional minor events, including headache,
dizziness, nausea, fatigue and hypotension, was similar to placebo.

"Our studies consistently have confirmed the two major attributes of the
REG1 system, rapid anticoagulant activity and rapid and predictable reversal
of this effect," stated David J. Mazzo, Ph.D., President and Chief Executive
Officer of Regado Biosciences. "Based on the encouraging Phase I study data,
we anticipate results from our ongoing Phase IIa studies evaluating REG1 in
patients undergoing elective PCI will further confirm that REG1 has the
potential to replace standard heparin therapy."
"In striving to meet the needs of individual patients in varied and
oftentimes complex settings, it is essential for physicians to quickly, safely
and effectively achieve the desired anticoagulation effect and, when required
for specific clinical indications, to attenuate or fully reverse this effect,"
stated Richard C. Becker, M.D., Professor of Medicine, Duke University Medical
Center, and Director, Duke Cardiovascular Thrombosis Center, Duke Clinical
Research Institute. "As we enter a new era of anticoagulant pharmacotherapy,
a therapeutic system offering these attributes would be of great benefit and
may have a profound impact on patient care."
Clinician-scientists from the Duke Clinical Research Institute (DCRI) and
Regado evaluated REG1 in three Phase I studies: Phase Ia, a healthy volunteer
drug dose-escalating pharmacokinetic-pharmacodynamic (PK-PD) study; Phase Ib,
a drug dose-escalating study in subjects with stable coronary artery disease
who were receiving aspirin with or without clopidogrel; and Phase Ic, a
multiple exposure, dose-ranging study in 39 healthy volunteers. Top-line
results from these three studies were presented last year at the American
Heart Association's 2007 Scientific Sessions and subsequently published in
top-tier scientific journals -- Circulation and the Journal of Thrombosis and
Haemostasis.
Regado is currently evaluating REG1 in 26 patients undergoing elective
percutaneous coronary intervention (PCI). The multi-center, open-label,
randomized Phase IIa study designated REVERSAL-PCI will assess whether REG1
can replace standard heparin therapy during the performance of PCI with
stenting.
REG1 is the first specific, direct-acting anticoagulant controllable by
its matched reversal agent. Regado is developing REG1 for use in patients
suffering from acute coronary syndrome who undergo coronary revascularization
procedures. These procedures, which include percutaneous coronary
intervention (PCI) and coronary artery bypass grafting (CABG), put patients at
a high risk for therapy-related bleeding complications. REG1 is being
developed initially to increase therapeutic flexibility and improve patient
outcomes in coronary revascularization procedures. Intellectual property
covering this technology derives from work originating in Duke University
Medical Center's Division of Surgical Sciences, which was not involved in the
subsequent clinical studies. Duke exclusively licensed the technology to
Regado and will receive certain payments from Regado under this license.
REG1 is a two-component system, consisting of an aptamer-based
anticoagulant and its matched reversal agent. The REG1 anticoagulant
component, RB006, is a single-stranded, nucleic acid aptamer. RB006
selectively and potently binds to and inhibits factor IXa, a protein that is
critical to blood coagulation. The reversal agent, RB007, is a complementary
nucleic acid that binds to and neutralizes RB006. The amount of RB007
administered allows physicians to fine tune the pharmacodynamic effect of
RB006, from slight reduction in anticoagulation all the way to complete
reversal.
About Regado Biosciences
Regado Biosciences is pioneering a new therapeutic field with the
discovery and development of two-component drug systems, comprising an aptamer
therapeutic that can be controlled directly by a specific and matched reversal
agent. Regado's technology is designed to give physicians the ability to
directly control and fine tune each product's therapeutic effect. This
control and flexibility allows physicians to meet the individual needs of each
patient independent of the setting. Regado initially is focusing its
discovery and development efforts on acute care injectable antithrombotics, a
multi-billion dollar market in need of therapeutics with improved safety
profiles.
Current investors in Regado include Domain (Princeton, NJ), Quaker
BioVentures (Philadelphia, PA), Aurora Funds (Durham, NC) and Caxton Advantage
Life Sciences Fund (New York, NY), as well as individual investors, including
Robert Kierlin.
SOURCE Regado Biosciences, Inc.

media, Justin Jackson, jjackson@burnsmc.com, or investors Juliane Snowden,
jsnowden@burnsmc.com, both of Burns McClellan, Inc., for Regado Biosciences,
Inc., +1-212-213-0006