Regado Biosciences announced
the journal Circulation has published clinical data from the Company's REG1
anticoagulation system Phase 1b dose-escalation study. REG1 is a
two-component system comprised of an aptamer-based anticoagulant, RB006,
and its matched antidote, RB007, which binds to and neutralizes RB006. The
published study is the first to show in patients that RB006 effectively
inhibited the activity of Factor IXa, a protein essential to blood clotting
and that RB006's activity was reversed rapidly and safely by RB007.
The article, titled, "A Phase 1b Randomized Study of
Antidote-Controlled Modulation of Factor IXa Activity in Patients with
Stable Coronary Artery Disease", was authored by clinical researchers from
the Duke Clinical Research Institute and Regado. The study showed an
intravenous (IV) bolus injection of RB006 achieved a prompt, consistent,
and dose-dependent prolongation of activated partial thromboplastin time
(aPTT), a well-accepted surrogate marker of the blood's ability to clot. In
addition, a 1 mg/kg dose of RB006 resulted in essentially complete Factor
IXa inhibition. The study also demonstrated an IV bolus injection of RB007
administered in a 2:1 antidote:drug ratio successfully reversed prolonged
aPTT within a median of one minute, with no rebound for up to seven days.
There were no major bleeding or other serious adverse events observed in
the study, which included 19 subjects who received dual antiplatelet
therapy.
"The data published in Circulation provide further evidence of the REG1
system's ability to rapidly and predictably anticoagulate and then to
reverse this effect as needed in a reproducible manner. The results also
show the pharmacologic data translated well from healthy volunteers to the
CAD patient population," stated Doug Gooding, Chief Executive Officer of
Regado Biosciences. "Following the completion of a Phase 1 program in a
total of 173 patients, the Company now is evaluating this first-in-class
antidote-reversible therapeutic system in a Phase 2a trial in patients
undergoing elective percutaneous coronary intervention. If the results of
this study further confirm the Phase 1 data, we are confident this system
may be able to transform the way anticoagulation is approached in coronary
revascularization procedures and other acute care settings."
Data from Regado's Phase 1b study were presented previously at the
American Heart Association's 2007 Scientific Sessions.
About REG1 Anticoagulation System Clinical Program
Regado's Phase 1 program included three studies. A Phase 1a study
enrolled 84 healthy volunteers, while the Phase 1b study reported above
enrolled 50 patients with stable coronary artery disease who were receiving
aspirin with or without clopidogrel. In addition, the Company conducted a
Phase 1c clinical study, in which 39 healthy volunteers were randomized to
receive either three consecutive REG1 treatment cycles or placebo. The
Phase 1c study further demonstrated RB007's ability to reverse the
anticoagulant effect of RB006 either completely or partially, depending on
the level of dosing of RB007.
Based upon the combined results of the Company's Phase 1a, 1b, and 1c
studies, Regado initiated REVERSAL-PCI, a multi-center, open-label,
randomized Phase 2a clinical study of the REG1 anticoagulation system. The
Phase 2a study is enrolling 26 patients undergoing elective percutaneous
coronary intervention (PCI) to assess whether REG1 can replace standard
heparin therapy during the performance of coronary balloon angioplasty
dilatation and stenting in patients at low risk for complications
associated with therapy-related bleeding or heart attack.
About REG1 Anticoagulation System
Regado's lead product candidate, REG1, is the first specific,
direct-acting, antidote-controlled anticoagulant ever described. Regado is
developing REG1 for use in patients suffering from acute coronary syndrome
who undergo coronary revascularization procedures. These procedures, which
include coronary artery bypass grafting (CABG) and percutaneous coronary
intervention (PCI), 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.
REG1 is a two-component system, consisting of an aptamer-based
anticoagulant and its matched antidote. 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 antidote component, RB007, is a complementary
nucleic acid that binds to and neutralizes RB006. The binding of RB007 to
RB006 causes the predictable and rapid reversal of RB006 that allows the
patient's blood to return to normal.
About Regado Biosciences
Regado Biosciences is pioneering a new therapeutic field with the
discovery and development of drug:antidote systems. Regado's drug:antidote
systems are designed to give physicians the ability to fine-tune the
therapeutic effect desired for each patient and in each setting. A spin-out
of the Department of Surgery at Duke University Medical Center, Regado was
created to answer the therapeutic needs identified by its scientific
founders.
The Company's proprietary platform technology enables the discovery of
oligonucleotide-based drug-antidote pairs to any target protein. Regado
initially is focusing its discovery and development efforts on the acute
care injectable antithrombotics, a multi-billion dollar market in need of
therapeutics with improved safety profiles. Potential future indications
for Regado's technology include acute coronary syndromes and other coronary
revascularization procedures that would benefit from the availability of an
antidote-reversible agent.
Regado Biosciences
regadobiosciences