The
New England Journal of Medicine
recently published positive phase II data on
Amgen's
(
AMGN
) psoriasis candidate, brodalumab (formerly known as AMG 827).
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
) 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.
AMGEN INC (
AMGN
): Free Stock Analysis Report
IDERA PHARMACT (
IDRA
): Free Stock Analysis Report
LILLY ELI & CO (
LLY
): Free Stock Analysis Report
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