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Results from the 12-week randomized, double-blind, placebo-controlled, dose-ranging phase II study, conducted with 198 patients suffering from moderate-to-severe plaque psoriasis, showed that brodalumab achieved its primary endpoint. The mean percentage improvement in psoriasis area and severity index (PASI) was higher in all brodalumab arms compared to placebo.
Mean improvements of 85.9%, 86.3% and 45% were observed in PASI scores for the 140 mg, 210 mg and 70 mg doses of brodalumab (administered every other week), respectively, compared to a 16% improvement in the placebo arm. Amgen said that a mean PASI improvement of 76% was observed in the monthly dose of brodalumab 280 mg arm. In contrast, 30% of patients in the placebo arm reported a worsening of disease.
Meanwhile, 77%, 72% and 38% of patients in the 140 mg brodalumab group achieved PASI 75, PASI 90 and PASI 100, respectively. In the 210 mg brodalumab arm, 82%, 75% and 62% of patients achieved PASI 75, PASI 90 and PASI 100, respectively.
Common side effects in the combined brodalumab arms included common cold, upper respiratory tract infection and injection site redness with two cases of grade three neutropenia being reported in the 210 mg brodalumab arm.
Brodalumab, a highly-selective human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor, is also being evaluated by Amgen for the treatment of psoriatic arthritis and asthma. Based on the encouraging data from the phase II psoriasis study, Amgen will most likely move the candidate into phase III studies for the psoriasis indication in 2012.
We note that other companies like Eli Lilly ( LLY - Analyst Report ) and Idera Pharmaceuticals ( IDRA ) are also working on developing treatments for psoriasis. In fact, phase II data on Eli Lilly’s candidate was also published in the New England Journal of Medicine recently. Amgen already has a presence in the psoriasis market in the form of Enbrel.
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