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Avalo Therapeutics (AVTX) investor relations material
Avalo Therapeutics Stifel Virtual Immunology and Inflammation Forum summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Company overview and lead program
Developing AVTX-009, a high-affinity anti-IL-1β antibody, currently in Phase 2b 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 compared to competitors.
The drug is designed for better lesion penetration, longer half-life, and improved dosing frequency.
Scientific rationale and competitive landscape
IL-1β is identified as the main pathologic driver in HS, with IL-1α not elevated in lesions and not contributing to chronic inflammation.
Previous anti-IL-1α therapies showed no effect in HS, supporting the focus on IL-1β.
Lutacisumab data in severe HS patients validated the IL-1β mechanism, showing significant efficacy even in TNF inhibitor failures.
AVTX-009 aims for higher efficacy due to 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 due to limited response rates.
Clinical trial design and progress
Phase 2b trial includes three arms (two active, one placebo), 222+ patients, 16-week duration, and HiSCR75 as the primary endpoint.
Dosing regimens include monthly and biweekly options with loading doses, aiming for rapid therapeutic levels and patient-friendly administration.
Enrollment is highly competitive but progressing well, with 75% completed and full enrollment expected in the fall.
Comprehensive endpoints include skin pain, quality of life, and draining tunnel assessments.
Statistical analysis will use appropriate imputation methods, avoiding exclusion of patients for incidental antibiotic use.
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