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].

AVTX-009 and HS Market - AVTX-009, an anti-IL-1β mAb, is a lead compound with potential for best-in-class and best-in-disease profile in hidradenitis suppurativa (HS)[7] - The HS market is expected to grow to over $10 billion by 2035[8] - Avalo is enrolling patients in a Phase 2 LOTUS trial for HS, with topline data expected in mid-2026[8] - AVTX-009 has 15x higher affinity than lutikizumab, potentially predictive of higher efficacy and less frequent dosing[10] Financials and Strategy - Avalo expects its cash runway to extend into 2028[8] - As of March 31, 2025, Avalo had approximately $125 million in cash[70] - As of March 31, 2025, Avalo's adjusted market capitalization was $284.5 million, based on an adjusted common share count of 35.5 million and a stock price of $8.01[70] IL-1β and AVTX-009 Advantages - IL-1β gene expression is up to 100x increased in HS lesions compared to healthy skin[26] - AVTX-009 is designed to target the inflammatory driver of Hidradenitis Suppurativa (HS) to address significant unmet need[15] - AVTX-009 has a subcutaneous bioavailability of 73% and a half-life of 19 days[35]