AbbVie and Boehringer Ingelheim to develop and commercialize BI 655066

[Fred]

More good news for BI 655066 after AbbVie and Boehringer Ingelheim today announced a global development and commercialization collaboration. BI 655066 has achieved psoriasis clearance for 66 months from one shot in a previous study.

Quote:

---

AbbVie (NYSE: ABBV) and Boehringer Ingelheim today announced a global collaboration to develop and commercialize BI 655066, an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis. AbbVie and Boehringer Ingelheim also are evaluating the potential of this biologic therapy in Crohn's disease, psoriatic arthritis and asthma. In addition to the anti-IL-23 antibody, AbbVie gains rights to an anti-CD-40 antibody, BI 655064, currently in Phase 1 development. Boehringer Ingelheim will retain responsibility for further development of BI 655064, and AbbVie may elect to advance the program after completion of certain undisclosed clinical achievements.

"This collaboration positions BI 655066 as AbbVie's lead investigational compound in psoriasis, complementing our robust immunology pipeline," said Michael E. Severino, M.D., executive vice president and chief scientific officer, AbbVie. "Our expertise in developing and commercializing the world's leading biologic, combined with Boehringer Ingelheim's clinical success to-date will enable us to offer patients a new treatment option with the potential to meaningfully improve the standard of care."

"Our Immunology R&D teams have successfully brought forward compounds that have the potential to transform the way immune diseases are treated. I believe the collaboration with AbbVie is the best way to ensure broad access for patients to BI 655066 and BI 655064," said Dr. Michel Pairet, Member of the Board of Managing Directors responsible for R&D nonclinical at Boehringer Ingelheim. "Our company remains strongly committed to establishing immunology as a core area of expertise and building our pipeline and capabilities in this important therapeutic area."

Recent Phase 2 head-to-head study results in patients with moderate-to-severe plaque psoriasis showed that BI 655066 had greater efficacy over ustekinumab, a commonly used treatment for this life-impacting skin condition. 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 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).

Source: abbvie.com

More on BI 655066

Psoriasis clear 66 months after one subcutaneous injection of trial drug BI 655066

New psoriasis treatment BI 655066 worked faster than Stelara