Avalo Therapeutics announces first patient dosed in Phase 2 LOTUS trial

Avalo Therapeutics announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa. AVTX-009 is a humanized monoclonal antibody that binds to interleukin-1beta with high affinity and neutralizes its activity. The LOTUS Trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa. Subjects will be randomized to receive either one of two doses of AVTX-009 or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response at Week 16. Secondary objectives include but are not limited to: proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System, draining fistula count, abscess and inflammatory nodule count and patients achieving at least a 30% reduction on a numerical rating scale in Patient’s Global Assessment of Skin Pain. The number of patients with anti-drug antibodies, safety, and tolerability will be assessed.