Avalo Begins Phase 2 LOTUS Trial Dosing for Hidradenitis Suppurativa Treatment

Avalo Therapeutics, Inc. has announced the commencement of its Phase 2 LOTUS trial, marking the first dosing of a patient with AVTX-009 for the treatment of hidradenitis suppurativa (HS). AVTX-009, a humanized monoclonal antibody (IgG4), targets and neutralizes interleukin-1β (IL-1β), a key player in inflammatory diseases.

The LOTUS Trial aims to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults suffering from moderate to severe hidradenitis suppurativa. The study is randomized, double-blind, placebo-controlled, and operates on a parallel-group design. Participants will be randomly assigned to one of three groups: two different dosages of AVTX-009 or a placebo, over a 16-week treatment period.

The primary measure of efficacy will be the proportion of subjects achieving a Hidradenitis Suppurativa Clinical Response (HiSCR75) by Week 16. Secondary objectives include the proportions of patients achieving HiSCR50 and HiSCR90, as well as changes from baseline in the International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count, and a 30% reduction in the Patient's Global Assessment of Skin Pain (PGA Skin Pain). Additionally, the trial will monitor the presence of anti-drug antibodies, safety, and tolerability.

Hidradenitis suppurativa is a chronic inflammatory skin condition which manifests as painful nodules, abscesses, and tunnels in areas such as the armpits, groin, and buttocks. This condition significantly diminishes the quality of life for those affected. It is often underdiagnosed or misdiagnosed, with prevalence estimates ranging between 0.2-1.7% of the global population. The exact cause of HS is not entirely understood, but it likely involves genetic, hormonal, and environmental factors. The limited treatment options available underscore the need for new therapeutic approaches. IL-1β is a crucial component in the inflammatory cascade that leads to HS, making it a validated target for treatment.

AVTX-009 works by binding to IL-1β with high affinity and neutralizing its activity. Given IL-1β's pivotal role in inflammation and tissue damage, therapies targeting this molecule could offer effective treatment for HS and other inflammatory diseases in dermatology, gastroenterology, and rheumatology.

Avalo Therapeutics is a clinical-stage biotechnology company specializing in immune dysregulation treatments. Its lead asset, AVTX-009, focuses on inflammatory diseases through the inhibition of IL-1β. Besides AVTX-009, Avalo's pipeline includes quisovalimab (an anti-LIGHT monoclonal antibody) and AVTX-008 (a BTLA agonist fusion protein).

The efficient execution by Avalo Therapeutics to start this trial represents a significant milestone. Dr. Garry Neil, Chief Executive Officer and Chairman of the Board, expressed excitement about the trial's progress and its potential to offer a best-in-class treatment for patients. The topline results from the LOTUS trial are anticipated to be released in 2026.