Date: 2015-10-08
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 24th European Academy of Dermatology and Venereology (EADV) congress in Copenhagen
Company: Boehringer Ingelheim (Germany)
Product: BI 655066
Action
mechanism: monoclonal antibody. 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.
Disease: moderate-to-severe plaque psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country:
Trial
details: The study investigated the efficacy and safety of the new compound versus the commonly used psoriasis treatment, ustekinumab. (NCT02054481)
Latest
news: * On October 8, 2015, Boehringer Ingelheim announced that new results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim’s investigational biologic compound BI 655066*, over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab. Patients also achieved this skin clearance significantly faster (approximately eight weeks versus approximately 16 weeks) and for more than two months longer (≥ 32 weeks versus 24 weeks) than those on ustekinumab. In addition, completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066* compared with ustekinumab (43 percent versus 15 percent). These 24-week findings from a Phase II study in psoriasis were presented in an oral presentation by Dr Kim A. Papp at the 24th European Academy of Dermatology and Venereology (EADV) congress in Copenhagen. The study investigated the efficacy and safety of BI 655066 versus ustekinumab in 166 patients.These data build on Phase II data presented earlier this year at the Annual Meeting of the American Academy of Dermatology (AAD) (See below). Primary endpoint results showed nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (PASI 90) after 12 weeks of treatment with BI 655066, compared to ustekinumab (77.1 percent versus 40 percent of patients). The new data further demonstrate that BI 655066 has similar safety and tolerability to ustekinumab, regardless of dose, with no serious drug-related side-effects. The most common side effects were runny nose, sore throat, and headache. The BI 655066 90mg (n=41) dose also showed superior efficacy, onset and duration of action over ustekinumab after nine months. Boehringer is currently planning multiple Phase III studies. * On March 20, 2015, Boehringer Ingelheim announced Phase II data from BI 65506611. 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% versus 40% of patients). BI 655066 had similar safety and tolerability to ustekinumab. 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. 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 180mg. 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 its label). All study treatments were given as an injection under the skin. Supporting Phase I data was published online in The Journal of Allergy and Clinical Immunology on March 12, 2015.
