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March 29, 2012

Amgen reports Phase 2 study results of psoriasis drug

The Phase 2 trial of Amgen's Brodalumab (formerly AMG 827) drug has reported positive results in patients with moderate to severe plaque psoriasis.

The Phase 2 trial of Amgen’s brodalumab (formerly AMG 827) drug has reported positive results in patients with moderate to severe plaque psoriasis.

Brodalumab is a human monoclonal antibody that selectively binds to and blocks signalling via the interleukin-17 (IL-17) receptor, thereby inhibiting the binding of several IL-17 family members associated with psoriasis.

The 12-week Phase 2 study was a randomised double-blind placebo-controlled dose-ranging trial designed to evaluate the efficacy and safety of brodalumab in moderate to severe plaque psoriasis.

In the study, treatment with brodalumab every other week achieved its primary endpoint of mean improvement in psoriasis area and severity index (PASI) scores of 85.9%, 86.3% and 45% versus 16% with placebo.

PASI score is a measure of psoriatic plaque redness, scaling and thickness and the extent of involvement in each region of the body.

The study also assessed secondary endpoints including PASI 75, PASI 90 and PASI 100, which indicate 75%, 90% and 100% reductions in patient PASI scores from baseline, respectively.

In patients dosed with 140mg of brodalumab, 77% achieved a 75% reduction in their PASI score, 72% achieved a 90% reduction and 38% experienced total clearance, and of the patients dosed with 210mg of brodalumab, 82% achieved a 75% reduction, 75% achieved a 90% reduction and 62% experienced total clearance.

Probity Medical Research, Ontario, Canada, director and lead author of the study Kim Papp said that in the Phase 2 study, brodalumab showed a high level of response in patients with moderate to severe plaque psoriasis with a rapid onset of action within days.

"Based on these results, additional clinical trials are warranted to further assess the safety and efficacy of brodalumab," Papp added.

Currently, brodalumab is being assessed for the treatment of psoriasis in Phase 2 and planned Phase 3 trials, psoriatic arthritis (Phase 2) and asthma (Phase 2).

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