Avalo Therapeutics Announces Completion of Enrollment in Phase 2 LOTUS Trial of AVTX-009 for the Treatment of Hidradenitis Suppurativa

Core Insights - Avalo Therapeutics has completed enrollment in its Phase 2 LOTUS trial for AVTX-009, exceeding the target of 222 patients with approximately 250 patients enrolled. Topline data is expected in mid-2026 [1][2]. Company Overview - Avalo Therapeutics is a clinical stage biotechnology company focused on developing IL-1β-based treatments for immune-mediated inflammatory diseases. The lead asset, AVTX-009, is currently in a Phase 2 clinical trial for hidradenitis suppurativa (HS) [3][4]. Trial Details - The LOTUS trial is a randomized, double-blind, placebo-controlled Phase 2 trial evaluating the efficacy, safety, and tolerability of AVTX-009 in adults with moderate to severe HS. The trial includes two dosing regimens and has a treatment phase of 16 weeks [2]. - The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include HiSCR50, HiSCR90, changes in the International HS Severity Score System (IHS4), and patient-reported pain assessments [2]. Mechanism of Action - AVTX-009 is a humanized monoclonal antibody that binds to interleukin-1β (IL-1β) with high affinity, neutralizing its activity. IL-1β is a pro-inflammatory cytokine involved in various diseases, and its inhibition has shown effectiveness in multiple immune-mediated inflammatory conditions [4].