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Psoriasis: BI 655066, an IL-23 p19 antagonist monoclonal antibody, more effective than Ustekinumab after 12 weeks


Phase II trial results from investigational compound BI 655066 were presented at 73rd Annual Meeting of the American Academy of Dermatology.
Nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin ( described as PASI 90 ) after 12 weeks of treatment with BI 655066 compared to Ustekinumab [ Stelara ] ( 77.1% versus 40% of patients ).
The study investigated the efficacy and safety of the new compound versus the commonly used psoriasis treatment, Ustekinumab.
BI 655066 had similar safety and tolerability to Ustekinumab.

In this primary phase II analysis, the selective IL-23 inhibitor BI 655066 was superior to Ustekinumab, an IL-12/23 inhibitor ( PASI 90 77.1% vs 40% ).

Using sPGA ( static Physician Global Assessment ) as a secondary outcome measure to determine psoriasis severity, 90% of patients in the study given BI 655066 had clear or almost clear skin compared with 67.5% for Ustekinumab.
These efficacy analyses were based on pooled dose results for BI 655066 of 90 and 180 mg.

In addition, results showed that more than double the percentage of psoriasis patients on BI 655066 achieved completely clear skin ( PASI 100 ) after 12 weeks ( 46% of patients on BI 655066 compared to 17.5% patients on Ustekinumab ).

The most commonly reported side-effects in the trial were a runny nose and sore throat ( nasopharyngitis ) and headache.

In the study, 166 patients were randomly assigned to one of three dose groups of BI 655066 ( 18, 90 or 180 mg ) or Ustekinumab ( one of two doses according to label ).
All study treatments were given as an injection under the skin.

Psoriasis is a chronic immune system disease. While the exact cause of psoriasis is unknown, it is associated with an overactive immune system that drives skin cells to grow at an abnormally fast rate ( up to 10x ) and accumulate to form itchy, red, flaky skin plaques.
This abnormal immune response is driven by immune cells and proteins that are released, known as cytokines. A cytokine called interleukin-23 ( IL-23 ) is one of the key drivers of psoriasis.
IL-23 activates and maintains several immune cells and leads to the production of other cytokines including IL-17 and IL-22. IL-17 and IL-22 have direct effects on the skin inducing skin inflammation that contributes to appearance or flare up of psoriasis.
BI 655066 has been specifically designed to target a key part of the IL-23 protein known as the p19 subunit that selectively blocks IL-23 and thus helps prevent the production of IL-17 and IL-22. ( Xagena )

Source: Boehringer Ingelheim, 2015

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