Pharmaprojects R&D Pipeline News Feed
First filing for J&J's novel anti-psoriasis antibody
10 Dec 2007
Sufferers of psoriasis in the EU and the US welcomed the news from Johnson & Johnson that it has filed for the approval of ustekinumab, its novel antibody for the treatment of moderate-to-severe plaque psoriasis, in these territories. Ustekinumab has been in development for the treatment of moderate-to-severe plaque psoriasis, and works by antagonizing the IL-12 and -23 receptors, making it a first-in-class treatment for psoriasis.
In a 52wk Phase III trial (PHOENIX 2) in 1230 psoriasis patients, ustekinumab met its primary endpoint at wk12, with 67 and 76% of patients on ustekinumab 45 and 90mg, respectively, achieving PASI75, cf 4% on placebo. Additionally, 42 and 51%, respectively, achieved PASI90 cf 1% on placebo. Similar results were observed in the placebo group 12wk after crossover to ustekinumab. A 5-year extension study and 2 further Phase III trials are ongoing.
Psoriasis is a recurring, autoimmunological skin disease caused by proliferation of epidermal cells. Patients are subjected to patches of dry, scaling patches and plaques. The full cause is not known; however, it is suspected to be genetic and is often associated with rheumatoid arthritis. There are 2 similar pipeline compounds not far behind ustekinumab – Abbott’s ABT-874 and Synta Pharmaceuticals’ STA-5326, both in Phase II trials.
