Avalo Therapeutics, Inc.

The company is a clinical stage biotechnology company focused on developing treatments for immune-mediated inflammatory diseases using IL-1β-based therapies. Its primary product candidate is abdakibart (AVTX-009), an anti-IL-1β monoclonal antibody. Abdakibart (AVTX-009) is currently in a Phase 2 clinical trial for hidradenitis suppurativa (HS), known as the LOTUS trial. The company aims to complete this Phase 2 trial and prepare for anticipated topline data readout in the second quarter of 2026, followed by planning for Phase 3 trials. The company's strategy includes advancing its pipeline through development to regulatory approval, with a near-term focus on the Phase 2 LOTUS trial in HS and preparing to initiate pivotal trials. It also seeks to acquire or in-license rights to and/or develop targeted, complementary preclinical and clinical stage compounds for immune-mediated inflammatory diseases. Additionally, the company may opportunistically out-license rights to compounds, indications, or geographies. Abdabibart (AVTX-009) is a high affinity, highly potent humanized IgG4 monoclonal antibody designed to specifically inhibit IL-1β and block downstream inflammatory pathways. IL-1β is a pro-inflammatory cytokine central to many human diseases, activating immune cells that produce other pro-inflammatory cytokines like IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling drives inflammation and contributes to autoimmune disorders, and IL-1β inhibition has shown effectiveness in various immune-mediated inflammatory diseases.