Avalo Therapeutics Completes Enrollment In Phase 2 LOTUS Trial Evaluating AVTX-009 For The Treatment Of Hidradenitis Suppurativa

Avalo Therapeutics, Inc., a clinical-stage biotechnology company focused on developing IL-1β-based therapies for immune-mediated inflammatory diseases, announced that it has successfully completed patient enrollment in its Phase 2 LOTUS trial evaluating AVTX-009 in adults with hidradenitis suppurativa (HS). The trial surpassed its original target of 222 participants, enrolling approximately 250 patients in total. Topline results from the study are expected to be available by mid-2026.

Dr. Garry Neil, Chief Executive Officer of Avalo Therapeutics, stated that completing enrollment in the LOTUS trial represents a significant step forward for the company’s AVTX-009 program. He noted that the strong participation from both investigators and patients highlights the substantial unmet medical need in HS, a chronic and painful inflammatory skin condition. Dr. Neil added that with AVTX-009’s high-affinity inhibition of IL-1β, Avalo aims to develop a treatment that could be both differentiated and potentially best-in-class for patients suffering from this debilitating disease.

The LOTUS trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 study designed to assess the efficacy, safety, and tolerability of AVTX-009 in adults with moderate to severe HS. Approximately 250 participants were randomized in a 1:1:1 ratio to receive one of two dosing regimens of AVTX-009 or a placebo over a 16-week treatment period.

The trial’s primary endpoint is the proportion of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16, which indicates a 75% reduction in inflammatory lesion count without any increase in abscesses or draining fistulas. Secondary endpoints include the proportion of patients achieving HiSCR50 and HiSCR90, along with changes from baseline in key clinical measures such as the International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count, and a 30% or greater reduction in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain).

Hidradenitis suppurativa is a chronic inflammatory condition characterized by painful nodules, abscesses, and tunnels in the skin, primarily affecting areas such as the underarms, groin, and buttocks. The disease significantly impacts quality of life, and current treatment options remain limited. By targeting IL-1β, a key driver of inflammation, AVTX-009 has the potential to offer a novel therapeutic approach for managing HS more effectively. Completion of patient enrollment in the LOTUS trial underscores Avalo Therapeutics’ continued progress in advancing innovative treatments for inflammatory diseases and brings the company one step closer to addressing the significant unmet needs of HS patients worldwide.