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Phase II LOTUS results presented at a European dermatology meeting found that about 43% of patients in each abdakibart dose group reached HiSCR75 at week 16, compared with about 25% on placebo. The investigational IL-1 beta inhibitor also showed differences from placebo on several measures as early as week 4, according to presenter Martina J. Porter; longer-term and phase III results are still needed.
Abdakibart, an investigational interleukin-1 beta inhibitor, produced higher week-16 rates of a stringent disease-response measure than placebo in the phase II LOTUS trial for hidradenitis suppurativa (HS), according to results presented at a European dermatology meeting. About 43% of patients in each of two dose groups reached HiSCR75, compared with about 25% of patients receiving placebo, offering an early efficacy signal ahead of planned phase III development.
The LOTUS study enrolled more than 240 patients, with about 80 in each of three groups: two abdakibart dosing arms and a placebo arm. The primary results described by presenter Martina J. Porter, MD, of Beth Israel Deaconess Medical Center, were measured at week 16. HiSCR75 refers to a 75% reduction in abscesses and inflammatory nodules without an increase in abscesses or draining tunnels, as defined for the trial measure.
Porter said the study showed an early separation between the abdakibart and placebo groups: differences on almost all of the endpoints discussed were apparent by week 4. The report did not provide detailed numerical results for those other measures, so the size and consistency of those differences cannot be assessed from the information presented.
On safety, Porter described the 16-week profile as clean, saying there was no increased infection risk observed. Injection-site reactions occurred across placebo and drug groups to a similar degree, and headaches were among the most common side effects. These are findings over the trial’s reported 16-week period; they do not establish longer-term safety.
A New Target for HS Treatment
The results add an investigational approach to a disease for which patients may face persistent, painful lesions and limited treatment options. Abdakibart targets IL-1 beta, an inflammatory signaling protein, and the reported HiSCR75 difference suggests the mechanism merits further study in HS. However, a phase II result is an early test of efficacy and safety, not proof that the drug will benefit patients in routine care.
The placebo group also matters to interpretation: about one in four placebo patients reached HiSCR75 at week 16. The difference between that rate and the roughly 43% in each drug arm is a trial finding, but the source report does not provide confidence intervals, statistical significance details, or a full analysis of how the result compares with other treatments. Those details are needed to judge the strength and clinical relevance of the signal.
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LOTUS Results at Week 16
The findings were presented at the European Academy of Dermatology and Venereology meeting in Vienna and discussed in a MedPage Today video published November 4, 2026. Porter said she presented the phase II study results on behalf of Avalo Therapeutics, which is developing abdakibart. The available report summarizes her remarks rather than providing a full trial publication or complete data tables.
HS is a chronic inflammatory skin condition, and treatment studies commonly track changes in abscesses and inflammatory nodules. Porter said week 16 is a key point for evaluating response and safety, while noting that outcomes over six months, 12 months and longer are also important because disease severity may continue to improve over time. The LOTUS findings therefore represent an interim-duration view, not an account of sustained benefit.
Limits of the Early Data
The reported results do not establish whether abdakibart will receive regulatory approval or how it would compare with existing HS treatments. The source does not give the trial’s full statistical analysis, exact dose levels, detailed results for each additional endpoint, or patient characteristics that could affect how broadly the findings apply.
It is also not clear from the report how long any response lasts, whether improvement continues beyond week 16, or what safety findings may emerge with longer exposure or a larger study population. Porter’s favorable safety comments describe the 16-week trial window and should not be read as a guarantee of safety for individual patients.
Phase III and Longer Follow-Up
Porter said abdakibart is expected to move into phase III testing. Those studies will need to test whether the week-16 response signal is reproduced in a larger or otherwise distinct population and provide more detail on dose, benefits, and risks. Longer follow-up will also be needed to assess whether responses persist or increase over six months and 12 months, as well as to monitor safety over time.
The source report did not provide a phase III start date, trial design, enrollment target, or timeline for new results. Until those details and additional data are available, abdakibart remains investigational and the phase II findings should be treated as promising but preliminary.
Key Questions
What did the LOTUS phase II trial find?
At week 16, about 43% of patients in each abdakibart dose group reached HiSCR75, compared with about 25% in the placebo group, according to presenter Martina J. Porter.
What is abdakibart?
Abdakibart is an investigational IL-1 beta inhibitor being studied as a treatment for hidradenitis suppurativa. The reported phase II results do not mean it is approved for use.
How soon did researchers report seeing differences from placebo?
Porter said differences on almost all of the endpoints discussed were apparent by week 4. The source report does not give numerical results for those early comparisons.
What safety findings were reported?
Porter described no increased infection risk during the 16-week study. Injection-site reactions occurred at similar degrees across the drug and placebo groups, and headaches were among the common side effects. Longer-term safety remains unknown.
What happens after the phase II results?
Porter said the drug is expected to move into phase III. The source did not specify the trial’s start date or design; later studies and longer follow-up will be needed to confirm efficacy and characterize risks.
Source: medpagetoday.com
