Avalo Therapeutics, Inc. announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1ß monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the Company to commence its Phase 2 (LOTUS) clinical trial in patients with HS. Avalo expects to enroll the first patient in its Phase 2 LOTUS Trial this year. 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 HS.

The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Subjects will be randomized (1:1:1) to receive either one of two doses of AVTX-009 or placebo. Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and tunnels that form in areas of the body such as the armpits, groin, and buttocks, severely impacting the quality of life of affected individuals.1 HS is often underdiagnosed or misdiagnosed and therefore estimates of HS vary between 0.2-1.7% of the population worldwide.2-5 The exact cause of HS is not fully understood but is believed to involve a combination of genetic, hormonal, and environmental factors.

While advances in treatment have been made, limited treatment options are available. IL-1ß plays a crucial role in the inflammatory cascade underlying HS, contributing to tissue damage, inflammation, and disease progression. Given the involvement of IL-1ß in the inflammatory process of HS, we believe therapies that target IL-1ß offer a potential treatment option for HS.

AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1ß (IL-1ß) with high affinity and neutralizes its activity. IL-1ß is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1ß is implicated in many autoimmune and inflammatory diseases.

IL-1ß is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1ß could be effective in HS and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology.