NORTH CHICAGO, Ill. & INGELHEIM, Germany—A global collaboration began this week between AbbVie and Boehringer Ingelheim for the development and commercialization of BI 655066, an anti-IL-23 monoclonal biologic antibody currently in Phase 3 development for psoriasis. AbbVie will gain rights to BI 655064, an anti-CD-40 antibody in Phase 1 development, with Boehringer Ingelheim retaining responsibility for further development of the compound. AbbVie can elect to advance the program once certain clinical achievements are reached.
Per the terms of the agreement, AbbVie will pay Boehringer Ingelheim $595 million up front, with the latter eligible to receive additional development and regulatory milestone payments, as well as royalties on net sales. AbbVie and Boehringer Ingelheim will initially share responsibility for future development of BI 655066, with AbbVie solely responsible for commercialization of the compound, while Boehringer Ingelheim will retain an option to co-promote it in asthma. The partners will set up a joint steering committee for the compound's development as well as the initial commercialization phase.
"This collaboration positions BI 655066 as AbbVie's lead investigational compound in psoriasis, complementing our robust immunology pipeline," Dr. Michael E. Severino, executive vice president and chief scientific officer of AbbVie, commented in a statement. "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."
In a recent Phase 2 head-to-head study in patients with moderate-to-severe plaque psoriasis, BI 655066 was found to demonstrate greater efficacy that ustekinumab, a commonly used treatment for plaque psoriasis. After nine months, 69 percent of patients in the trial who received BI 655066 treatment maintained clear or almost clear skin in the higher dose group, compared to 30 percent of patients on ustekinumab. Skin clearance was also achieved more rapidly—approximately eight weeks vs. roughly 16 weeks—and lasted more than two months longer—more than 32 weeks vs. 24 weeks—compared to those on ustekinumab. Completely clear skin was maintained after nine months in almost three times the percentage of patients receiving BI 655066 compared to those on ustekinumab (43 percent vs. 15 percent).
"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."
BI 655066, which is administered as a subcutaneous injection, was generally well tolerated in the 12-week treatment portion of the Phase 2 study. Patients reported serious adverse events in the BI 655066 18 mg treatment group (7 percent) and ustekinumab group (2.5 percent), though there were no serious adverse events in the 90 mg and 180 mg treatment groups. One patient in the BI 655066 18mg dose group discontinued treatment. The most common adverse events for patients receiving BI 655066 treatment were common cold and headache. The most common adverse events in the ustekinumab group were common cold, pain and redness at the injection site, sore throat and myalgia, each of which occurred in 5 percent of patients.
BI 655066 is in Phase 2 development for the treatment of Crohn's disease and asthma, and will soon enter Phase 2 development for psoriatic arthritis. Phase 2 data for its applicability in Crohn's disease will be presented at an upcoming medical meeting.
SOURCE: AbbVie press release