Abbott psoriasis drug succeeds in pivotal trial

Abbott Laboratories’ experimental psoriasis treatment briakinumab, which is awaiting U.S. and European approval decisions, demonstrated superior skin clearance rates compared with a commonly used medicine in a pivotal late-stage clinical trial, the company said on Monday.

In a 52-week study of 317 patients with moderate to severe psoriasis, the drug was significantly better than methotrexate in its ability to clear the unsightly, scaly and often painful skin patches associated with plaque psoriasis - a disease of the immune system.

At 24 weeks, 81.8 percent of briakinumab patients achieved at least a 75 percent skin clearance rate, compared with 39.9 percent for methotrexate.

After 52 weeks, 66.2 percent maintained at least a 75 percent clearance rate on the Abbott drug compared with 23.9 percent for methotrexate, according to data presented on Friday at the European Association of Dermatology and Venereology meeting in Gothenburg, Sweden.

Complete skin clearance was seen in 45.5 percent of briakinumab patients versus 9.2 percent for those who received methotrexate.

Briakinumab is a biotechnology drug that targets proteins that have been linked to inflammation called IL-12/23.

Abbott filed applications in the third quarter seeking U.S. and European approval of the drug and will likely receive those decisions in the second half of next year.

If approved, briakinumab would compete with Johnson & Johnson’s Stelara, a new drug from the same class.

The most commonly used biotech medicines for psoriasis, such as Amgen Inc’s Enbrel, target a protein known as tumor necrosis factor.

Briakinumab demonstrated superior skin clearance rates to Enbrel in earlier Phase III studies that also had data presented at the meeting in Sweden.

In the newest study versus methotrexate, there were three cases of cancer reported in the group that received the Abbott drug. There were also four patients who experienced serious infections (2.6 percent), compared with three (1.8 percent) among methotrexate patients, Abbott said.

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NEW York (Reuters)