Avalo Therapeutics Announces IND for AVTX-009 to Treat Hidradenitis Suppurativa

Following FDA review, Avalo’s IND application for AVTX-009 is active allowing Avalo to proceed with its Phase 2 trial (LOTUS) to evaluate the efficacy and safety of AVTX-009 in patients with hidradenitis suppurativa

Avalo Therapeutics, Inc. has announced that the FDA has activated the Investigational New Drug (IND) application for AVTX-009, a monoclonal antibody targeting interleukin-1β (IL-1β), for treating hidradenitis suppurativa (HS). This activation permits Avalo to begin its Phase 2 clinical trial, known as LOTUS, which aims to assess the safety and efficacy of AVTX-009 in individuals suffering from HS. The first patient enrollment in the LOTUS trial is anticipated to occur within this year.

Dr. Garry Neil, Avalo's Chief Executive Officer and Chairman of the Board, expressed pride in his team for reaching this milestone shortly after acquiring the product candidate in March 2024. He emphasized the potential of AVTX-009 to be superior in its class and indication due to its specific target, half-life, and potency. These attributes are expected to contribute to robust efficacy and ease of dosing, making the start of the LOTUS trial a significant step forward.

The LOTUS Trial is designed as a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial. It will involve approximately 180 adult participants with moderate to severe HS and will evaluate two different dosage regimens of AVTX-009. The primary efficacy measure will be the proportion of subjects achieving a 75% improvement in the Hidradenitis Suppurativa Clinical Response (HiSCR75) at the 16-week mark. Participants will be randomized in a 1:1:1 ratio to receive one of two doses of AVTX-009 or a placebo.

Hidradenitis Suppurativa is a chronic inflammatory skin disease marked by painful nodules, abscesses, and tunnels in areas like the armpits, groin, and buttocks, significantly affecting the quality of life of those afflicted. The prevalence of HS is estimated to be between 0.2% and 1.7% worldwide, although it is often underdiagnosed or misdiagnosed. The precise cause of HS remains unknown but is believed to involve genetic, hormonal, and environmental factors. Despite some therapeutic advances, treatment options for HS remain limited. IL-1β is known to play a critical role in the inflammatory processes of HS, leading to tissue damage and disease progression. Therefore, targeting IL-1β holds promise as a potential treatment strategy for HS.

AVTX-009 is a humanized monoclonal antibody (IgG4) that binds with high affinity to IL-1β, effectively neutralizing its activity. IL-1β is a validated therapeutic target as its overproduction or dysregulation is implicated in many autoimmune and inflammatory conditions. The inhibition of IL-1β by AVTX-009 could be beneficial not only for HS but also for a variety of other inflammatory diseases across dermatology, gastroenterology, and rheumatology.

Avalo Therapeutics focuses on treating immune dysregulation and has several candidates in their pipeline. In addition to AVTX-009, Avalo's portfolio includes quisovalimab, an anti-LIGHT monoclonal antibody, and AVTX-008, a BTLA agonist fusion protein. These candidates reflect Avalo's commitment to addressing inflammatory and autoimmune diseases.