AbbVie and Boehringer Ingelheim said they will partner to co-develop the latter’s Phase III psoriasis candidate BI 655066 and to assess the potential of the biologic in Crohn’s disease, psoriatic arthritis, and asthma.
The collaboration will generate $595 million upfront for Boehringer, plus potential development and regulatory milestone payments and royalties on net sales.
The companies cited positive Phase II data—specifically study results in patients with moderate-to-severe plaque psoriasis that showed BI 655066 had greater efficacy over ustekinumab.
AbbVie and Boehringer Ingelheim cited data presented at last year’s 24th European Academy of Dermatology and Venereology (EADV) Congress, which showed:
- After 9 months, 69% of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin—Psoriasis Area and Severity Index (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 8 weeks vs. approximately 16 weeks) and for more than 2 months longer (≥32 weeks vs. 24 weeks) than those on ustekinumab.
- Completely clear skin (PASI 100) was maintained after 9 months in nearly triple the percentage of patients on BI 655066 compared with ustekinumab (43% vs. 15%).
Serious adverse events were reported for patients in the BI 655066 18-mg treatment group (7.0%) and ustekinumab group (2.5%), but there were no serious adverse events in the 90-mg and 180-mg treatment groups, the companies said.
“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.
Immunology is one of AbbVie’s six areas of drug development focus: The other five are kidney disease, liver disease, neuroscience, oncology, and women’s health.
Added 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 selectively blocks interleukin-23 (IL-23), a key protein involved in skin inflammation that has been linked to an overactive immune system and is one of the key drivers of psoriasis. In addition to psoriasis, BI 655066 is also in Phase II development for Crohn’s disease and asthma and is about to enter Phase II for psoriatic arthritis
Phase II data for Crohn’s disease is set to be presented at an upcoming medical meeting.
In addition to BI 655066, an anti-IL-23 antibody, AbbVie will gain rights to an anti-CD40 antibody, BI 655064, now in Phase I development for lupus nephritis, with potential for other immune diseases, such as Crohn’s disease and ulcerative colitis. Boehringer Ingelheim will retain responsibility for further development of BI 655064, although AbbVie may elect to advance that clinical program after completion of undisclosed clinical achievements.