First patient dosed in phase 2 trial evaluating AVTX-009 for hidradenitis suppurativa

Key takeaways:

• The first of approximately 180 subjects in this phase 2 trial has been dosed with AVTX-009 for the treatment of hidradenitis suppurativa.
• Topline results are expected in 2026.

Researchers have dosed the first patient in a phase 2 trial evaluating AVTX-009 for the treatment of hidradenitis suppurativa, Avalo Therapeutics announced in a press release.

“Hidradenitis suppurativa (HS) is a disease that can significantly impact quality of life and there is a need for improved treatment options,” Garry Neil, MD, CEO and chairman of the board at Avalo Therapeutics, said in the release. “We believe AVTX-009’s high potency could make it a best-in-class and best-in-indication treatment option for patients suffering from HS.”

According to the release, AVTX-009 is a humanized monoclonal antibody that binds to interleukin-1 beta to neutralize its activity. The randomized, double-blind, placebo-controlled parallel-group phase 2 LOTUS trial will evaluate the efficacy of AVTX-009 for the treatment of moderate to severe HS.

Approximately 180 adults with moderate to severe HS have been enrolled in the trial. Over a 16-week period, each patient will be randomly assigned to receive one of two AVTX-009 doses or placebo.

Researchers will evaluate the success of the drug based on the primary efficacy endpoint, which is a proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 by the end of the study.

Secondary endpoints will also be evaluated including disease severity scores, inflammatory nodule counts and skin pain reports.

According to Neil, topline results will be released in 2026.