Regado Biosciences Releases Positive Phase 2a Data for the Reversible Anticoagulant System REG1

Regado Biosciences Releases Positive Phase 2a Data for the Reversible Anticoagulant System REG1 at the European Society of Cardiology Congress In Barcelona, Spain

BASKING RIDGE, N.J., Aug. 31 /PRNewswire/ -- Regado Biosciences, a privately
held company leading the development of antithrombotic aptamers with active
control agents, announced today that the results of a  Phase 2a clinical trial
of their lead product, the anticoagulant system REG1, were released at the
European Society of Cardiology Congress in Barcelona, Spain.  The results,
detailed in a poster entitled, "First Clinical Application of an Actively
Reversible Direct Acting Factor IXa inhibitor in Elective Percutaneous
Intervention", were presented by Dr. Mauricio Cohen, lead investigator of the
study from the University of Miami-Miller School of Medicine.  The poster was
presented on Sunday, August 30, 2009. 

This was the first study to evaluate REG1 in a clinical setting involving
percutaneous coronary intervention (PCI).  REG1 is a two component system
consisting of RB006, a direct FIXa inhibitor and RB007, the active, specific
control agent for RB006.  This phase 2a study (REVERSAL-PCI) was an
open-label, randomized, multicenter study that evaluated feasibility and
safety during elective PCI comparing the REG1 anticoagulant system with
unfractionated heparin in patients with coronary artery disease.  All 26
patients in the study received aspirin and clopidogrel as background therapy.
The primary endpoint of the study was major bleeding within 48 hours.
Important secondary endpoints were a composite of death, myocardial infarction
or urgent target vessel revascularization within 14 days and pharmacodynamic
measures.  The three arms of the study were designed to measure both total and
partial anticoagulant reversal, with all REG1 subjects undergoing planned
early arterial catheter sheath removal.

The study demonstrated that the REG1 System enabled safe and effective PCI.
All procedures were successfully completed in the REG1 cohorts with no signs
of catheter or guidewire thrombosis.  Coagulation parameters demonstrated
effective, predictable and consistent ranges of anticoagulation during the
study.  Reversal of the anticoagulant effects of RB006 using RB007 was rapid,
predictable and reproducible and permitted planned early arterial catheter
sheath removal.  The study also demonstrated that REG1 was well tolerated
during PCI.

"The REVERSAL-PCI study represents the first study in which a reversible
aptamer anticoagulation system was employed during an interventional
cardiology procedure.  These results demonstrate the potential for the use of
the REG1 S-system in patients undergoing PCI", stated Dr Mauricio Cohen, the
principle investigator for the study.

"This first clinical application of the REG1 System in PCI is a significant
milestone in the development of this innovative and unique product.  Based on
these positive results, we can confidently advance to the next stage of
development with the initiation of the 'RADAR' trial, our phase 2b study",
stated Chris Rusconi, PhD, Chief Scientific Officer and Co-Founder of  Regado
Biosciences.   President and CEO David J. Mazzo, PhD added,  "We are delighted
and honored  to have the REVERSAL-PCI data accepted and presented at such a
prestigious meeting as the European Society of Cardiology Congress". 

ABOUT REGADO BIOSCIENCES:  Regado Biosciences is pioneering a new therapeutic
technology with the creation and development of two-component drug systems.
Each system comprises a nuclease-stabilized RNA aptamer that can be controlled
directly by its specific and complementary oligonucleotide active control
agent.  This technology is being applied to injectable antithrombotics,
including anticoagulants and antiplatelet agents, a multi-billion dollar
market in need of therapeutics with improved safety profiles and a greater
degree of therapeutic control.  Regado's technology is designed to give
physicians the ability to actively and directly control each system's
therapeutic effect providing a safe and unique approach to personalized
medicine.

ABOUT THE REG1 SYSTEM:  Regado's lead program, the anticoagulant system REG1,
consists of two parenteral agents, the first being a potent and highly
selective Factor IXa inhibitor (RB006) and the second being its complementary
active control agent (RB007).  RB007 can be used to selectively completely or
partially reverse the anticoagulant effect of RB006.

ABOUT APTAMERS:  RB006 is a member of a class of compounds called aptamers.
Aptamers are single stranded oligonucleotides that adopt a specific
conformation enabling direct, specific inhibition of the targeted protein.  A
key unique feature of aptamers derives from the fact that they are formed from
nucleic acids.  As such, their pharmacologic activity can be controlled by a
matched, complementary oligonucleotide active control agent (the Watson-Crick
base pair complement of a fraction of the agent to be controlled), which can
bind to the aptamer, removing it from its target and reversing it biologic
effects

Suggested Articles

Pliant Therapeutics will use the proceeds to push its lead program through midstage trials in fibrotic liver and lung diseases.

Cancer biotech Novellus has struck a deal with Plexxikon for its early- to midstage BRAF-inhibiting hopeful PLX8394.

Chinook Therapeutics is set to merge with fallen Big Pharma darling Aduro Biotech to create a kidney disease player with $180 million in cash.