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March 15, 2012

Abbott initiates Phase 3 studies of Humira drug

Abbott has begun two Phase 3 clinical trials to demonstrate the safety and efficacy of an investigational use of its Humira (adalimumab) drug in adult patients with moderate to severe hidradenitis suppurativa (HS).

Abbott has begun two Phase 3 clinical trials to demonstrate the safety and efficacy of an investigational use of its Humira (adalimumab) drug in adult patients with moderate to severe hidradenitis suppurativa (HS).

The two Phase 3 trials, M11-313 and M11-810, are 36-week multinational randomised double-blind placebo-controlled studies, conducted at around 50 sites worldwide, including Australia, Canada, Europe and the US, to assess clinical outcomes and safety of adalimumab in around 600 patients with moderate to severe HS.

The trials include participants who have been diagnosed with moderate to severe HS for at least one year prior to enrolment with stable disease for the last two months, lesions in two distinct areas, and have had an inadequate response to at least a three-month trial of an oral antibiotic for treatment of moderate to severe HS.

Humira in combination with methotrexate is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients not previously treated with methotrexate.

Abbott Clinical Development immunology divisional vice president John Medich said the company is investigating adalimumab as a treatment option for patients with hidradenitis suppurativa, and these studies represent another important step in continuing this exploration.

Roskilde Hospital University of Copenhagen Department of Dermatology professor and chairman Gregor Jemec said treating hidradenitis suppurativa has remained a challenge for specialists and patients, since there is no EMA-approved therapy available.

"This investigation of adalimumab in HS patients is potentially a significant step for this underserved patient population," Jemec added.

Hidradenitis suppurativa is a chronic, inflammatory skin disease characterised by painful, recurrent abscesses, and nodules that primarily appear in the groin or under the armpits or breasts and start out as tender, swollen bumps.

The company said the findings from the Phase 3 trials are likely to be announced next year.

Abbott is focused on the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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