Alexion Announces Positive Clinical Results from Phase
I/II Study Of C5 Complement Inhibitor in Rheumatoid
Arthritis Patients
NEW HAVEN, Conn., April 21 /PRNewswire/ -- Alexion Pharmaceuticals, Inc.
(Nasdaq: ALXN - news) today announced that
it has completed preliminary analysis of its Phase I/II study of its
anti-inflammatory complement inhibitor drug candidate 5G1.1 in
rheumatoid arthritis patients. The trial was designed to gather clinical
data regarding the safety profile and biological effects of a
single administration of 5G1.1 in this patient population. The
preliminary analysis demonstrated that the drug was well tolerated,
showed a potent biologic effect, and was associated with a significant
reduction in a validated, objective measurement of clinical
disease activity in these patients.
``The results of this study are encouraging since they demonstrate for
the first time that a complement inhibitor can produce a
sustained, well-tolerated reduction in complement activity in rheumatoid
arthritis patients,'' said Dr. Leonard Bell, President and
Chief Executive Officer of Alexion. ``Further, the observation that the
drug significantly and beneficially affected objective
measurements of disease activity in these patients supports a clinical
proof-in-principle for the role of C5 Inhibitors in the treatment
of rheumatoid arthritis patients.''
The Phase I/II multi-center, double-blinded, placebo-controlled,
ascending-dose trial examined the safety and biologic activity of
5G1.1 in 40 patients with mild to moderate rheumatoid arthritis, each of
whom received a single dose of the drug, ranging from 0.1
to 8.0 mg/kg. Of primary importance, 5G1.1 was found to be safe and well
tolerated, and had no detectable immunogenicity in the
study population. Further, a single dose of 5G1.1 potently and rapidly
blocked complement activity in a dose-dependent fashion
for up to two weeks.
The sustained and potent complement inhibition after a single dose was
associated with a beneficial clinical effect, with the highest
dose (8 mg/kg; n=6) resulting in a significant 30 percent reduction in
C-reactive protein levels (P<.05), as compared to
placebo-treated patients, in which C-reactive protein increased 24
percent (P=ns). C-reactive protein, a validated measurement of
clinical disease activity in rheumatoid arthritis, is considered the
most objective component of the American College of
Rheumatology's definition of improvement criteria for rheumatoid
arthritis. In the study, drug administration was also associated
with a trend in reductions in other, more subjective, measurements of
disease activity, including tender joint count, swollen joint
count, patient's global assessment of disease and patient's global
assessment of pain.
``The need for multiple therapeutic alternatives in rheumatoid arthritis
remains great, since, for many patients, the observed benefits
of most existing treatments may be offset by potentially serious side
effects,'' commented Dr. Christopher Mojcik, a clinical
rheumatologist and Senior Director of Clinical Development at Alexion.
``Based upon the results of the current Phase I/II trial, we
are moving rapidly to commence Phase II efficacy trials in expanded
rheumatoid arthritis populations.''
Approximately 2,500,000 patients currently receive therapy for
rheumatoid arthritis in the U.S. Rheumatoid arthritis is a disease in
which the immune system attacks primarily multiple joints and, in fact,
the whole body. This chronic immune attack frequently leads
to involvement of multiple organs in the body and fatigue, in addition
to severe joint destruction, pain, and disfigurement.
Alexion's C5 inhibitors (5G1.1 and 5G1.1-SC) are specific and potent
recombinant drugs which are designed to intervene in the
complement cascade. The Company believes that these proprietary C5
Inhibitors intervene at an optimal point which generally
preserves the normal disease-preventing functions of complement proteins
while generally inhibiting the disease-causing actions.
5G1.1 is a novel fully humanized monoclonal antibody, specifically
designed to deliver potent anti-complement and
anti-inflammatory activity to patients suffering from chronic
inflammatory diseases, including the autoimmune disorders rheumatoid
arthritis and systemic lupus.
Alexion Pharmaceuticals, Inc. was founded in 1992 and is engaged in the
development of selective immunotherapeutic drugs that
generally are designed to inhibit the disease-causing segments of the
immune system while preserving the disease-preventing
aspects of the immune system. The Company is developing three technology
platforms: C5 Complement Inhibitors and Apogen
T-Cell Therapeutics which together target severe cardiovascular and
autoimmune disorders; and xenografts for organ
transplantation.
This news release contains forward-looking statements. Such statements
are subject to certain factors which may cause Alexion's
plans to differ or results to vary from those expected including
unexpected pre-clinical or clinical results, the need for additional
research and testing, delays in manufacturing, access to capital and
funding, delays and adverse changes in development of
commercial relationships and a variety of risks set forth from time to
time in Alexion's filings with the Securities and Exchange
Commission, including but not limited to the risks discussed in
Alexion's Annual Report on Form 10-K for the year ended July 31,
1998. Alexion undertakes no obligation to publicly release results of
any of these forward-looking statements which may be made
to reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events.
SOURCE: Alexion Pharmaceuticals, Inc.