Abbott's Investigational Treatment ABT-874 Shows Positive Results In Phase II Psoriasis Study
05/07/07
New Phase II study
results show Abbott's investigational treatment, ABT-874, reduced Psoriasis Treatment
symptoms significantly in the majority of patients treated. At 12 weeks,
nine out of 10 patients with moderate to severe psoriasis achieved 75
percent improvement in psoriasis signs and symptoms in four of the five
dosing groups receiving ABT-874, versus 3 percent of patients receiving
placebo. Also, more than half of patients achieved 90 percent improvement,
in the same four of five ABT-874 dosing groups, versus 0 percent of those
receiving placebo. The results will be presented next week at the Society
for Investigative Dermatology annual meeting in Los Angeles. ABT-874 is a
fully human monoclonal antibody designed to target and neutralize
interleukin-12 and interleukin-23, two proteins associated with
Inflammation in psoriasis and other autoimmune disorders.
ABT-874 represents a novel approach to treating psoriasis, targeting a
part of the inflammatory response that is not addressed by any therapy
available today. Abbott's biologic drugs in development, including ABT-874,
are designed to selectively inhibit proteins that are responsible for
inflammation, such as pro-inflammatory interleukins or tumor necrosis
factor- alpha. Abbott plans to begin Phase III psoriasis studies with
ABT-874 later this year.
"These early results are promising and warrant further development of
ABT-874 as an additional treatment option for moderate to severe psoriasis
patients," said Kenneth Gordon, M.D., associate professor of dermatology,
Northwestern University, Feinberg School of Medicine, head, Division of
Dermatology, Evanston Northwestern Healthcare, and study investigator.
"There is a significant unmet need among these patients, as many of them
continue to struggle with this isolating, painful disease."
Psoriasis is a chronic autoimmune disease affecting 125 million people
worldwide. About 25 percent have moderate to severe disease. The condition
speeds the growth cycle of skin cells and results in thick, scaly areas of
skin. The most common form of psoriasis appears as red, raised areas of
skin covered with flaky white scales, which may itch or burn. Psoriasis is
more than skin lesions; it is painful and can impact many aspects of a
person's life from professional and social activities to personal
relationships. People with psoriasis may also suffer from poor self-image
and social isolation. While psoriasis can occur in people of all ages, it
typically appears between the ages of 15 and 35. Currently, there is no
cure for psoriasis.
Study Background and Results
One hundred eighty patients with moderate to severe psoriasis were
enrolled in a 12-week, double-blind, placebo-controlled study. Patients
were randomized evenly to six treatment groups: a single, subcutaneous
200-mg injection of ABT-874 at week zero; 100 mg every other week (eow) for
12 weeks; 200 mg weekly for four weeks; 200 mg eow for 12 weeks; 200 mg
weekly for 12 weeks; or placebo. The primary endpoint was the proportion of
patients achieving 75 percent improvement in the degree and severity of
skin lesions after 12 weeks, measured by the Psoriasis Area and Severity
Index (PASI).
Results at 12 weeks showed ABT-874 was significantly more effective
than placebo. At least 90 percent of patients achieved PASI 75 in all
ABT-874 treatment groups except the single-dose group (200 mg at week
zero). (Results were, respectively, 63 percent, 93 percent, 90 percent, 93
percent, and 90 percent, vs. 3 percent of those receiving placebo; p<0.001
for all groups.) Also, in the same four treatment groups, more than half of
patients achieved 90 percent improvement in skin clearance (results were,
respectively, 17 percent, 53 percent, 63 percent, 77 percent, 53 percent,
vs. 0 percent of those receiving placebo; p<0.001 for all groups except the
single-dose group, 200mg at week 0).
The most common adverse events observed were injection site reactions,
nasopharyngitis (inflammation of the nose and pharynx), upper respiratory
infections and headache.
"We're very excited about these promising Phase II results," said
Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical
Development at Abbott. "In all but one of the dosing groups in this study,
at least 90 percent of patients showed significant improvement, and many
experienced almost complete clearance. We look forward to studying ABT-874
further."
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative
treatments for immunologic diseases. The Abbott Bioresearch Center, founded
in 1989 in Worcester, Mass., United States, is a world-class discovery and
basic research facility supporting research and development of biologic
treatments. Abbott Biotechnology Limited, which opened earlier this year in
Barceloneta, Puerto Rico, United States, is the main production facility
for Abbott's anti-TNF treatment and one of the world's largest centers for
production of monoclonal antibodies.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals, devices and diagnostics. The
company employs 65,000 people and markets its products in more than 130
countries.
Abbott
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