Avalo Therapeutics (AVTX) Stifel Virtual Immunology and Inflammation Forum summary

Company overview and lead program

• Developing AVTX-009, a high-affinity anti-IL-1β antibody, currently in phase IIb for hidradenitis suppurativa (HS), with full enrollment expected by end of year and data anticipated mid-2026.

• AVTX-009 targets IL-1β, a key driver of inflammation in HS, with higher affinity and specificity than competitors.

• The antibody is designed for better lesion penetration, longer half-life, and improved bioavailability, supporting a favorable dosing regimen.

Scientific rationale and competitive landscape

• IL-1β is highly upregulated in HS lesions, while IL-1α is not, making β the primary target for chronic inflammation.

• Previous anti-IL-1α trials showed no effect, supporting the focus on IL-1β.

• Lutikizumab data in severe, TNF-inhibitor-refractory HS patients validated the IL-1β mechanism, showing significant efficacy.

• AVTX-009 aims for higher efficacy than lutikizumab due to its pure IL-1β targeting and higher affinity.

• The market is shifting from TNF inhibitors to IL-17s, but there remains a need for alternative mechanisms like IL-1β.

Clinical trial design and progress

• Phase IIb trial includes three arms (two active, one placebo), targeting 222+ patients, using HiSCR75 as the primary endpoint.

• Dosing regimens: high dose monthly with loading, or biweekly, both with rapid achievement of therapeutic levels.

• Additional endpoints include IHS-4, skin pain, quality of life, and draining tunnels.

• Enrollment is highly competitive but progressing well, with 75% completed and full enrollment expected in fall.

• Topline data for the LOTUS trial expected by mid-2025.