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Boehringer Ingelheim’s Investigational Biologic Cleared Skin Better, Faster, and for Longer Than Ustekinumab in Phase II Psoriasis Study

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, Boehrninger Ingelheim announced on October 8, 2015. 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 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, M.D., Ph.D., President of Probity Medical Research, Waterloo, Ontario, Canada. "Achieving clear skin quickly and maintaining clearance is an important goal for patients who have to deal with the daily impact of psoriasis." These meaningful 24-week findings from a Phase II study in psoriasis were presented on October 8, 2015 in an oral presentation by Dr. Papp at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark. His presentation was titled “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.” The clinical study (https://clinicaltrials.gov/ct2/show/NCT02054481) 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).

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 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."

Note that BI 655066 is an investigational compound; its safety and efficacy have not been established.

The data discussed in this announcement represent results for the BI 655066 180 mg dose regimen delivered at weeks 0, 4, and 16. The BI 655066 90 mg dose also showed superior efficacy, duration and onset of action over ustekinumab.

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 0, 4 and 16.

The BI 655066 90mg (n=41) dose also showed superior efficacy, onset, and duration of action over ustekinumab after 9 months.

More patients with moderate-to-severe psoriasis maintained almost clear skin (PASI 90) with BI 655066 compared to those on ustekinumab (81 percent vs. 30 percent).

More patients on BI 655066 had completely clear skin (PASI 100) compared with ustekinumab (54 percent vs. 15 percent).

An exploratory single dose of BI 655066 18mg (n=43) was also studied. Ustekinumab 45mg/90mg (n=40) was delivered as an injection under the skin at weeks 0, 4 and 16.

BOEHRINGER INGELHEIM

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing, and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making More Health" and caring for its employees. Respect, equal opportunities, and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

[Boehringer Ingelheim press release] [Boehringer Ingelheim web site]

[European Pharmaceutical Review article]