For the first time, Boehringer Ingelheim announced Phase II data from its investigational compound BI 655066*. 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 (77.1 percent versus 40 percent of patients).1 The study (NCT02054481) investigated the efficacy and safety of the new compound versus the commonly used psoriasis treatment, ustekinumab.1 BI 655066 had similar safety and tolerability to ustekinumab.1 The new data were presented in a late-breaker session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, California.
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," commented K. Alexander Papp, MD, PhD, President of Probity Medical Research, Waterloo, Ontario, Canada. "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."
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%).1 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.1 These efficacy analyses were based on pooled dose results for BI 655066 of 90 and 180mg.1 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).1 The most commonly reported side-effects in the trial were a runny nose and sore throat (nasopharyngitis) and headache.1
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 its label).1 All study treatments were given as an injection under the skin.1
"These Phase II study results in psoriasis mark a major milestone in our growing immunology research and clinical programme," said Dr Steven Padula, Therapeutic Area Head Medicine Immunology at Boehringer Ingelheim. "We are planning Phase III studies in psoriasis and are actively recruiting clinical trial investigators. Our ambition is to bring forward ground breaking new medicines to transform the lives of patients with immune diseases."
Supporting Phase I data was published online in The Journal of Allergy and Clinical Immunology.
Psoriasis is a chronic immune system disease.2 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.2 This abnormal immune response is driven by immune cells and proteins that are released, known as cytokines.2 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.