AbbVie (ABBV) Piper Sandler Virtual Novel Targets in Immunology Symposium summary

Key data readouts and clinical differentiation

• Lutikizumab and RINVOQ are being developed for hidradenitis suppurativa (HS), with a focus on clinical differentiation through a mechanistically distinct approach targeting IL-1 alpha and beta.

• Lutikizumab's bispecific targeting of IL-1 alpha and beta is seen as crucial due to their synergistic roles in HS pathology.

• Phase II data for lutikizumab show strong efficacy in both biologic-experienced and naive HS patients, with differentiated results.

• Double-blind week 16 data for both lutikizumab and RINVOQ in HS are expected by year-end.

• Conventional wisdom suggests higher efficacy in biologic-naive patients, but lutikizumab has shown meaningful effects even in TNF-failure populations.

Competitive landscape and development strategy

• The HS development landscape includes IL-1 beta-specific agents and OX40 TNF-directed bispecifics, with safety and immunogenicity challenges noted for some competitors.

• Targeting both IL-1 alpha and beta is considered superior to beta alone, potentially blocking compensatory mechanisms and providing synergistic effects.

• Anti-TNF bispecifics face immunogenicity issues, prompting a shift toward novel mechanisms.

IBD pipeline and combination approaches

• Multiple combination studies are ongoing in IBD, including SKYRIZI with lutikizumab, TL1A-directed treatments, and alpha-4 beta-7 agents.

• Subcutaneous SKYRIZI data are expected this year, potentially enhancing market position.

• Alpha-4 beta-7 and TL1A combinations are prioritized, with phase transitions anticipated soon.

• TREM1, a novel mechanism, is being evaluated as monotherapy, with potential for future combinations.