Avalo Therapeutics Announces Long-Acting Anti-IL-1β Antibody Program With Potential Applications in HS

Avalo Therapeutics announced the advancement of AVTX-010, a next-generation, long-acting anti-interleukin-1β (IL-1β) monoclonal antibody (mAb) being developed for potential use in hidradenitis suppurativa (HS) and other immune-mediated inflammatory diseases.¹ The company plans to submit an Investigational New Drug (IND) application for AVTX-010 to the US Food and Drug Administration (FDA) in the first half of 2027.

Future Development

AVTX-010 is an engineered anti-IL-1β mAb designed to extend dosing intervals while building on the profile established by Avalo’s lead asset, abdakibart. The company is developing the molecule with the goal of providing less frequent dosing options for chronic inflammatory diseases, which Avalo believes may improve treatment convenience, adherence, and patient experience.

“Less frequent dosing is an important driver of physician and patient preference in chronic inflammatory diseases and we believe AVTX-010 may further strengthen our potential in HS, while creating opportunities to expand into additional indications where extended dosing intervals may improve treatment convenience, adherence, and overall patient experience,” Garry Neil, MD, chief executive officer of Avalo, said in a statement. “We are also encouraged by the productive engagement with FDA, which enables a streamlined path to bring AVTX-010 to first-in-human studies.”¹

The company expects AVTX-010 may strengthen its HS development strategy while creating opportunities to evaluate the molecule in additional inflammatory indications where extended dosing intervals may provide clinical benefits. Avalo plans to continue advancing abdakibart into a pivotal phase 3 registrational program while expanding its pipeline with AVTX-010.

Supporting Topline Data

The advancement of AVTX-010 follows recent positive topline data from abdakibart’s phase 2 LOTUS trial (NCT06603077) in HS.² The randomized, double-blind, placebo-controlled study enrolled 253 patients and assessed efficacy, safety, and tolerability over a 16-week treatment period.2 One group received a 600 mg loading dose followed by 300 mg every 4 weeks, while the second group received a 300 mg loading dose followed by 150 mg every 2 weeks.

The primary endpoint was the proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at week 16. HiSCR75 response rates were 42.2% in the 150 mg group and 42.9% in the 300 mg group, compared with 25.6% in the placebo arm. These represent the highest absolute improvements observed in trials of similar size or larger evaluating this endpoint, and the consistency of response across both dosing strategies suggests a robust treatment effect.

MORE ON HS

The safety profile of abdakibart was favorable over the 16-week study period. Mild and moderate treatment-emergent adverse events occurred at similar rates across both active treatment arms and the placebo group. The most commonly reported adverse events were headache and nausea. Abdakibart also demonstrated statistically significant improvements across key secondary endpoints, regardless of prior biologic exposure. These included:

• Proportion of participants achieving HiSCR50 and HiSCR90
• Change from baseline in International HS Severity Score System (IHS4)
• Change in draining fistula count, abscess, and inflammatory nodule count
• Proportion of participants achieving at least a 30% reduction in Patient’s Global Assessment of Skin Pain (PGA Skin Pain)

Potential Role in Hidradenitis Suppurativa

AVTX-010 is designed to inhibit IL-1β, a pro-inflammatory cytokine involved in the pathogenesis of multiple immune-mediated inflammatory conditions. Abdakibart is a humanized IgG4 monoclonal antibody that binds IL-1β with high affinity and neutralizes its activity. The company plans to explore AVTX-010 as part of its broader pipeline strategy.

AVTX-010 is intended to provide an extended dosing profile, although specific dosing schedules and clinical trial plans have not yet been disclosed. Avalo said it has had productive interactions with the FDA regarding the development of AVTX-010, which the company believes will support a streamlined path toward first-in-human studies. The planned IND submission in 2027 will allow the company to seek authorization to begin clinical testing.

References

1. Avalo Therapeutics Expands Pipeline with AVTX-010, a Long-Acting Next-Generation Anti-IL-1β Antibody. News release. Globe Newswire. Published June 16, 2026. Accessed June 16, 2026. https://www.globenewswire.com/news-release/2026/06/16/3312405/0/en/avalo-therapeutics-expands-pipeline-with-avtx-010-a-long-acting-next-generation-anti-il-1%CE%B2-antibody.html

2. Avalo Therapeutics Achieves Positive Topline Results in Phase 2 LOTUS Trial of Abdakibart (AVTX-009) in Moderate to Severe Hidradenitis Suppurativa. News release. GlobeNewswire. Published May 5, 2026. Accessed June 16, 2026. https://www.globenewswire.com/news-release/2026/05/05/3288197/0/en/avalo-therapeutics-achieves-positive-topline-results-in-phase-2-lotus-trial-of-abdakibart-avtx-009-in-moderate-to-severe-hidradenitis-suppurativa.html?_gl=1*1q6dxyr*_up*MQ..*_ga*MTk0ODQyMzkwOS4xNzc4MDcyNzEx*_ga_B6167QB2TF*czE3NzgwNzI3MTAkbzEkZzAkdDE3NzgwNzI3MTAkajYwJGwwJGgxODUyMzEyMzU.*_ga_ERWPGTJ5X8*czE3NzgwNzI3MTAkbzEkZzAkdDE3NzgwNzI3MTAkajYwJGwwJGgw