PBR Staff Writer Published 23 March 2015

Boehringer Ingelheim has reported positive results from a Phase II trial that evaluated the efficacy and safety of the new investigational compound BI 655066 versus ustekinumab in patients with moderate-to-severe plaque psoriasis.

The trial showed that nearly double the percentage of patients achieved clear or almost clear skin after 12 weeks of treatment with BI 655066 compared to ustekinumab.

The company said that BI 655066 had similar safety and tolerability compared to ustekinumab.

Primary Phase II analysis from the trial showed that the selective IL-23 inhibitor BI 655066 was superior to ustekinumab, an IL-12/23 inhibitor.

The efficacy analyses were based on pooled dose results for BI 655066 of 90and 180mg.

Probity Medical Research president Alexander Papp said: "The results of this study are compelling. Patients showed significant skin improvement with BI 655066 compared to ustekinumab, a widely acknowledged and accepted standard of treatment for moderate-to-severe psoriasis.

"These results are particularly encouraging given the study focused on a new treatment goal of PASI 90. The results showed that more patients treated with BI 655066 reached this rigorous primary endpoint.

"Furthermore, we saw that patients continued to achieve clear or almost clear skin beyond week 12. Achieving clear or almost clear skin can make a real difference to patients as they have to deal with the daily impact of psoriasis."

During the trial, a total of 166 patients were randomly assigned to one of three dose groups of BI 655066 18mg, 90mg or 180mg, or ustekinumab.

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Boehringer reports positive results from Phase II psoriasis trial