• 39 percent more patients maintained clear or almost clear skin (PASI 90) on BI 655066 after nine
months, compared to ustekinumab1
• Nearly triple the percentage of patients maintained completely clear skin (PASI 100) on BI 655066 after
nine months, compared to ustekinumab1
• Clear skin or almost clear skin (PASI 90) was achieved faster and maintained for more than two months
longer with BI 655066 compared with ustekinumab1
RIDGEFIELD, Conn., and Copenhagen, October 8, 2015 - 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.1 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).1
"These results are striking. They further strengthen our understanding of the potential skin improvement that can be achieved with BI 655066, in moderate-to-severe plaque psoriasis. We saw a third more patients achieve clearer skin in a short time period. And this clearance was maintained longer compared to the commonly used treatment ustekinumab," commented Kim A. Papp, MD, PhD, President of Probity Medical Research, Waterloo, Ontario, Canada. "Achieving clear skin quickly and maintaining clearance is an important goal for patients that have to deal with the daily impact of psoriasis."
These meaningful 24-week findings from a Phase II study in psoriasis were presented today in an oral presentation by Dr. Kim A. Papp at the 24th European Academy of Dermatology and Venereology (EADV) congress in Copenhagen.
The study (NCT02054481) investigated the efficacy and safety of BI 655066 versus ustekinumab in 166 patients.1 These data build on Phase II data presented earlier this year at the Annual Meeting of the American Academy of Dermatology (AAD). 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.1 The most common side effects were runny nose, sore throat, and headache.1
"The results are an exciting milestone in Boehringer Ingelheim's growing immunology pipeline. These Phase II study results represent a major step towards our vision of transforming the treatment of immune diseases and the patients affected by it," said Dr. Steven Padula, Therapeutic Area Head Medicine Immunology at Boehringer Ingelheim. "We look forward to continued research and are currently planning multiple Phase III studies."
Additional trial information
The data discussed in this press release represent results for BI 655066 180mg (n=42) injection under the skin, delivered at weeks zero, four and 16.
The BI 655066 90mg (n=41) dose also showed superior efficacy, onset and duration of action over ustekinumab after nine months.1
An exploratory single dose of BI 655066 18mg (n=43) was also studied.1
Ustekinumab 45mg/90mg (n=40) was delivered as an injection under the skin at weeks zero, four and 16.
Registered media can view the abstract online.
For additional information, click here to view the Facts about Psoriasis fact sheet.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim has a robust Immunology research and clinical program, covering a wide range of immune diseases, including psoriasis, psoriatic arthritis, Crohn's disease and lupus nephritis.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
If you are attending the EADV congress, visit us at the Boehringer Ingelheim booth, number 147.
*BI 655066 is not approved by regulatory authorities and its safety and efficacy is being investigated.
1K Papp et al. 2015. Onset and duration of clinical response following treatment with a selective IL-23p19 inhibitor (BI 655066) compared with ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. 24th European Academy of Dermatology and Venereology (EADV) congress, Copenhagen, Denmark, 7-11th October 2015 [Presentation]
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