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Amgen and AZ's psoriasis antibody beats Stelara in study

Brodalumab cleared all skin lesions in 37% compared to Stelara’s 18.5%

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Amgen and AstraZeneca (AZ) have reported that their experimental psoriasis therapy brodalumab has outperformed Johnson & Johnson's blockbuster rival Stelara in a head-to-head trial.

Interleukin-17 (IL-17) inhibitor brodalumab was shown to be superior to IL-12/IL-23 blocker Stelara (ustekinumab) at clearing skin lesions in patients with moderate-to-severe plaque psoriasis in the AMAGINE-3 trial, said the two companies.

After 12 weeks' treatment, the highest dose of brodalumab (210mg) given every two weeks achieved a 75% improvement on the psoriasis area severity index (PASI) score in 85% of patients, compared to 69% of those on Stelara.

Moreover, complete clearance of all skin lesions (PASI 100) was seen in 37% of the 210mg brodalumab group and 18.5% of those on J&J's drug. A lower dose of brodalumab (140mg) achieved PASI 75 and PASI 100 scores in 69% and 27% of patients, respectively.

The efficacy data for brodalumab are in line with the results of a placebo-controlled study (AMAGINE-1) reported earlier this year. A third trial called AMAGINE-2 - also comparing brodalumab to Stelara - should report later this year and if positive should lead to regulatory filings for the drug.

Stelara is riding the crest of a wave at the moment as a psoriasis therapy and is on course to top $2bn in sales this year, with turnover rising more than 40% to $1.5bn in the first nine months of 2014. J&J filed for approval to extend the use of the drug to include children as well as adults last month.

While the data for brodalumab is encouraging, the psoriasis sector as a whole looks set to become increasingly competitive, with Novartis and Lilly both developing their own anti-IL-17 candidates.

Novartis' secukinumab is the furthest ahead in development having been recommended for approval by an FDA advisory committee last month with data showing it was superior to Amgen's TNF antagonist Enbrel (etanercept), while Eli Lilly's ixekizumab has cleared phase III trials and is due to be filed in the coming months.

Additional competition is coming from Celgene's already-approved oral therapy Otezla (apremilast) - which is also predicted to become a blockbuster - and J&J's Stelara follow-up guselkumab, which is claimed to have a superior clinical profile.

"Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals," said Amgen's R&D head Sean Harper.

"These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance."

Brodalumab was highlighted in AZ's strategy presentation earlier this year as having the potential to reach somewhere between $500m and $1.5bn in peak sales, assuming it is also approved in follow-up indications psoriatic arthritis and asthma.

Article by
Phil Taylor

12th November 2014

From: Research

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