Alexion Reports Interim Analysis of Clinical Safety and Efficacy Data
from Phase II Rheumatoid Arthritis Trial Increased ACR20 Response Rate Observed
with 5G1.1 Treatment
CHESHIRE, Conn., Jan 29, 2001 /PRNewswire via COMTEX/ -- Alexion
Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced interim results of a
recently completed Phase II trial in patients with rheumatoid arthritis treated
with 5G1.1, Alexion's anti-inflammatory C5 Inhibitor monoclonal antibody. The
prospectively identified primary endpoint of improvement in ACR (American
College of Rheumatology) 20 score was successfully met in one of the 5G1.1
treated groups after three months of chronic treatment.
To more fully discuss these preliminary results, as previously announced, the
company will webcast a conference call this morning, January 29, 2001 at 9:00 AM
eastern time at alxn.com . The conference call can also be accessed
by calling 800-233-2795 (US) or 785-832-1523 (International).
In a double-blind, randomized, placebo-controlled trial which enrolled 209
patients at 28 clinical sites in the United States, patients with mild to
moderate disease undergoing treatment with moderate doses of methotrexate were
evaluated in one of four treatment arms. Patients were treated with placebo
(n=55), 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks and
then once every month (Induction/monthly;n=53), 5G1.1 at 8 mg/kg intravenous
injection once per week for four weeks and then once every two weeks
(Induction/biweekly;n=48), or 5G1.1 at 8 mg/kg intravenous injection once every
two weeks (Biweekly;n=53). The patients were evaluated after three months of
treatment for safety and efficacy and are then evaluated three months after
termination of the drug phase for safety only. While group data has been
unblinded at the interim analysis, individual patient data is currently
unavailable and will not be unblinded until completion of the final three month
safety observation period.
"5G1.1 targets the terminal complement cascade part of the innate immune
system," noted John Tesser, M.D., Chief Principal Investigator at the Phoenix
Center for Clinical Research, and a lead investigator in the current trial.
"This study describes a new potential therapy which is novel and unique and
which differs from all other available biologic therapies for rheumatoid
arthritis. These interim results suggest an important step forward on the path
to demonstrating that 5G1.1 may have important clinical activity in the
treatment of rheumatoid arthritis."
At the interim three month evaluation, 5G1.1 administration appeared to be safe
and well tolerated and we will continue to monitor safety in the second three
month period. The adverse event profile at three months was comparable to
placebo, with the most common adverse events being nausea and diarrhea. The
interim results after only three months of treatment showed that the
Induction/monthly group met the primary endpoint of the trial, improvement in
ACR20 score after three months of treatment. ACR20 score means that a patient
had a 20% improvement in tender and swollen joint count plus 20% improvement in
at least 3 of 5 of the following criteria: patient pain assessment, physician
global assessment, patient global assessment, patient self-assessed disability
and acute phase reactant. The ACR20 response in the Induction/monthly group was
43% as compared to the 20% ACR20 response in the placebo group. Both
Induction/monthly and Induction/biweekly groups also met the prospectively
identified secondary endpoint for changes in C-reactive protein after three
months of therapy (Placebo = +0.4 mg/dl; Induction/monthly = -0.4 mg/dl;
Induction/biweekly = -0.2 mg/dl). C-reactive protein is a validated objective
measurement of disease activity and is also a component of the ACR criteria. A
full analysis of the safety and efficacy data is expected to be available after
completion of the final three month safety period, at which time individual
patient data will also be unblinded. Additionally, we expect to submit available
data for presentation and publication at the earliest opportunity.
"We are encouraged by these preliminary data that 5G1.1 administration in the
Induction/monthly group met the primary endpoint of this trial, ACR20 score,
after only 3 months of therapy," commented Dr. Christopher Mojcik, a clinical
rheumatologist and Vice President of Clinical Development at Alexion.
"Additionally, we are also encouraged that both induction arms suggested
clinical activity since they each met an important secondary endpoint with a
reduction in C-reactive protein at three months. It is also noteworthy that the
current results were obtained in a patient population expected to have
mild-to-moderate disease."
"The clinical data obtained in the interim analysis of this study is
encouraging, since, if confirmed in subsequent Phase III trials, the data from
this study suggest that 5G1.1 may be able to provide a new biologic approach for
the chronic treatment of patients with rheumatoid arthritis," stated Leonard
Bell, M.D., President and Chief Executive Officer of Alexion. "Pending a full
evaluation of the interim data and final six month safety data from this trial,
and in conjunction with planned discussions with the FDA, we expect to initiate
a Phase III efficacy trial with 5G1.1 in rheumatoid arthritis patients at the
earliest possible opportunity."
It is estimated that more than two million Americans are affected by rheumatoid
arthritis, a disease in which the immune system attacks multiple joints as well
as the whole body. This chronic immune attack frequently involves multiple
organs in the body leading to the onset of fatigue, severe joint destruction,
pain and disfigurement.
Alexion is engaged in the discovery and development of therapeutic products
aimed at treating patients with a wide array of severe disease states, including
cardiovascular and autoimmune disorders, inflammation and cancer. Alexion's two
lead product candidates are currently in eight clinical development programs.
Alexion is developing its antibody fragment pexelizumab in collaboration with
Procter & Gamble, and has completed a Phase IIb efficacy and safety study in CPB
patients, and together the firms are currently conducting two large Phase II
studies in acute myocardial infarction patients. Alexion's other lead product
candidate, 5G1.1, has recently completed the treatment phase of this Phase II
efficacy trial for the treatment of rheumatoid arthritis. 5G1.1 is also in a
Phase II efficacy trial for the treatment of membranous nephritis and in Phase
Ib pilot studies for treatment of psoriasis, dermatomyositis, and pemphigoid.
Through its wholly owned subsidiary, Alexion Antibody Technologies, Inc.,
Alexion is engaged in discovering and developing a portfolio of additional
antibody therapeutics targeting severe unmet medical needs. This press release
and further information about Alexion Pharmaceuticals, Inc. can be found on the
World Wide Web at: www.AlexionPharm.com . |
