Avalo Highlights >250-Patient Phase II AVTX-009 Completion and $10 Billion HS Market
Avalo said its AVTX-009 Phase II hidradenitis suppurativa trial enrolled over 250 patients, with last patient visit due by end of March and data cleaning set to take 4-8 weeks. Plans Phase III enrollment in early 2027, forecasts hidradenitis market exceeding $10 billion, highlights AVTX-009’s 7-10x IL-1β affinity versus lutikizumab.
1. Phase II Trial Status
Avalo’s Phase II hidradenitis suppurativa trial for AVTX-009 enrolled over 250 patients using HiSCR75 endpoint, exceeding initial plans of 222 to ensure adequate powering for subpopulations. The last patient visit is slated by end of March, followed by four to eight weeks of database cleaning and analysis for a near-term readout.
2. AVTX-009 Antibody Differentiation
AVTX-009 is a human monoclonal antibody with 7-10x higher IL-1β binding avidity and a longer off-time than AbbVie’s lutikizumab, potentially enhancing lesion penetration via an affinity gradient in ‘pus under pressure.’ This high affinity could sustain IL-1β suppression below inflammation-driving levels.
3. Development Plans and Market Opportunity
Avalo plans an End-of-Phase II meeting with the FDA and Phase III enrollment in early 2027, targeting a manageable safety profile that may include bacterial infections and low-grade neutropenia. Management projects the global hidradenitis market to exceed $10 billion over five to six years, underscoring AVTX-009’s commercial potential.