Avalo Therapeutics hits primary endpoint in Phase 2 hidradenitis suppurativa trial

Avalo Therapeutics has reported positive topline results from its Phase 2 LOTUS trial of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS), with the IL-1β inhibitor meeting its primary endpoint at both doses studied. The company plans to advance the drug into a registrational Phase 3 program on the strength of the data.

CEO Garry Neil framed the results as validation of the underlying mechanism: “We are proud to report that abdakibart has delivered a strong, consistent, and deep response across both the HiSCR75 and HiSCR50 endpoints in our Phase 2 trial. This achievement powerfully validates the clinical promise of IL-1β inhibition for hidradenitis suppurativa. This de-risking data set gives us tremendous confidence to advance abdakibart into a pivotal phase 3 registrational program. With a differentiated and patient friendly potential monthly dosing regimen, we aim to offer a truly innovative mechanism of action to the HS community. Our heartfelt thank you goes to the patients, caregivers, investigators, and site teams whose dedication made this successful Phase 2 trial possible.”

the trial design

LOTUS enrolled 253 adults in a randomised, double-blind, placebo-controlled design across a 16-week treatment period. Participants were split 1:1:1 across two abdakibart regimens and placebo. One arm received a 600mg loading dose followed by 300mg every four weeks; the other received a 300mg loading dose followed by 150mg every two weeks. The primary endpoint was the proportion of patients achieving HiSCR75 — a 75% reduction in abscess and inflammatory nodule count — at week 16.

the results

Both doses cleared the primary endpoint with statistical significance: HiSCR75 response rates came in at 42.2% for the 150mg dose (p=0.018) and 42.9% for the 300mg dose (p=0.015), against a placebo rate of 25.6%. On a combined basis the response rate was 42.5% (p=0.004). Avalo notes these are the highest absolute HiSCR75 and HiSCR50 improvements recorded in any trial of this size or larger, at both individual and combined dose levels.

Key secondary endpoints — HiSCR50, change in IHS4 score, and change in draining tunnel count — all reached statistical significance, with numerically favourable trends across the remaining secondary measures. Notably, response rates were consistent regardless of whether patients had prior biologic exposure.

John Frew, professor of dermatology at the University of New South Wales, put the findings in clinical context: “These Phase 2 results are highly promising for the HS community. Achieving this level of improvement suggests that IL-1β inhibition with abdakibart may offer a meaningful new therapeutic option for people with HS who continue to struggle with this disease. The physical and emotional burden of HS is profound, and I am encouraged to see an investigational therapy showing such robust and clinically relevant results.”

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Related Topics and Keywords

Avalo Therapeutics, hidradenitis suppurativa trial, Phase 2 hidradenitis suppurativa trial, Phase 2 trial