AVTX · Avalo Therapeutics, Inc.

Avalo Therapeutics reported compelling topline data from the Phase 2 LOTUS trial (NCT06603077) of abdakibart (AVTX-009), an anti-IL-1β monoclonal antibody, in 253 adults with moderate to severe hidradenitis suppurativa (HS). The randomized, double-blind, placebo-controlled study met its primary endpoint of HiSCR75 at Week 16 with superior response rates of 42.2% for the 150mg Q2W regimen (300mg loading) and 42.9% for the 300mg Q4W regimen (600mg loading), versus 25.6% placebo (combined p=0.004). These represent the highest absolute improvements in HiSCR75 and HiSCR50 observed in trials of this size or larger. Key secondary endpoints, including HiSCR50, change in IHS4, and draining tunnel count, showed statistically significant benefits, with numerically favorable results across others. The HiSCR75 response was consistent in biologic-naïve and experienced patients (36.4% prior biologics use). Safety was favorable, with mild-to-moderate TEAEs (headache, nausea most common) comparable to placebo and no signals for neutropenia or serious infections. CEO Garry Neil highlighted the validation of IL-1β inhibition and confidence for Phase 3, noting potential monthly dosing. Full results will be presented at a medical congress. This de-risks abdakibart, positioning it for pivotal trials in HS, a chronic inflammatory disease affecting 0.7-1.2% of the U.S. population with significant unmet need.