Amgen, AstraZeneca report positive results from Phase III trial of psoriasis drug brodalumab

Psoriasis is a non-contagious chronic disease in which the immune system causes skin cells to grow at a faster rate.

The company said that the trial met all primary and secondary endpoints for both evaluated doses.

Brodalumab is the only investigational treatment currently in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor.

The trial’s primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75), and patients achieving clear or almost clear skin at week 12, according to the static Physician Global Assessment (sPGA 0 or 1).

The company said that a significantly higher proportion of patients treated with brodalumab achieved a PASI 75 response (primary endpoint), as well as PASI 90 and PASI 100 responses at week 12 (secondary endpoints) compared to placebo.

Amgen executive vice president of Research and Development Sean Harper said data from the AMAGINE-1 trial suggest that brodalumab may offer a new level of efficacy for patients with moderate-to-severe plaque psoriasis, a disease that affects more than 100 million people globally.

"This is the first read-out from our Phase 3 psoriasis clinical program and we look forward to obtaining additional Phase 3 data from our two head-to-head studies versus ustekinumab later this year," Harper said.

The trial evaluated the safety and efficacy of brodalumab given every two weeks via subcutaneous injection at two doses (140mg or 210mg) compared to placebo in patients with moderate-to-severe plaque psoriasis.

Image: In the Phase III AMAGINE-1 trial patients were given brodalumab via subcutaneous injection at two doses 140mg or 210mg compared to placebo. Photo: courtesy of vongvanvi/ freedigitalphotos.net