Abbott's Investigational Treatment Shows Positive Results In Phase II Psoriasis Study
New Phase II study results show Abbott's investigational treatment, ABT-874, reduced psoriasis 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.
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."