Avalo Therapeutics Completes Enrollment in Phase 2 LOTUS Trial for AVTX-009

Avalo Therapeutics, Inc. announced the completion of enrollment in its Phase 2 LOTUS trial for AVTX-009, a treatment for hidradenitis suppurativa (HS). The trial exceeded its target enrollment with approximately 250 patients participating. Topline data from the trial is expected in mid-2026. The LOTUS trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of AVTX-009 in adults with moderate to severe HS. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. AVTX-009 is a humanized monoclonal antibody that binds to interleukin-1β (IL-1β) with high affinity, aiming to offer a differentiated treatment option for HS patients.