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MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting
Business
Mar 28 2026
5 min read

MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting

  • Results from the Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS) show that clinical responses continue to improve to Week 40, with 62% of patients treated with sonelokimab (SLK) achieving HiSCR75 and up to 32% of patients achieving HiSCR100 
  • An analysis of different hallmark lesions of HS shows that up to 25% of patients achieved inflammatory remission at Week 40, defined as a 100% reduction in abscesses (A100), nodules (N100) and draining tunnels (DT100)
  • Patients treated with SLK also showed substantial improvements in HiSQOL items at week 40 versus baseline, ranging from 41% (pain), to 54% (walking, getting dressed) to 62% (down or depressed)
  • Up to 43% of patients achieved an at least 3-point improvement from baseline in the worst skin pain NRS, while 65% of patients achieved an improvement of at least 4 points from baseline in DLQI
  • No new safety signals were detected in the VELA trials to-date
  • Detailed results will be presented at the S034 Late-Breaking Research: Session 2 by Prof. Alexa Kimball, Investigator at Beth Israel Deaconess Medical Center, and Professor of Dermatology at Harvard Medical School, at the 2026 AAD Annual Meeting on March 28, 2026

ZUG, Switzerland, March 28, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (MoonLake or the Company), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today.

The Phase 3 VELA program in adults with moderate-to-severe HS used the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. Key secondary endpoints included the change from baseline in the HS Quality of Life score (HiSQOL) as well as other scores that reflect the evolving needs of HS patients, treating physicians and regulators. These included the percentage of participants achieving at least a 55% reduction in the International HS Severity Scoring System (IHS4-55), the percentage of participants achieving at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale (NRS) among participants with a baseline score of at least 3 points, and the percentage of patients achieving a Dermatology Quality of Life Index (DLQI) total score improvement of ≥4 (minimal clinically important difference), among participants with a baseline DLQI ≥4. A total of 838 patients were enrolled across both trials. Following the primary endpoint at Week 16, patients in the placebo arm were switched to receive SLK treatment for the remaining duration of the trial until Week 52. Patients originally randomized to the SLK arm continued to receive SLK at the monthly 120mg maintenance dose. All patients have completed Week 40 and discontinuation rates were at the low end to those observed in other pivotal HS trials. After Week 52, patients have the opportunity to switch into a two-year open-label extension trial.

SLK demonstrated continued improvement of clinical scores and Patient Reported Outcomes (PROs) at Week 40. Across both VELA-1 and VELA-2, 62% of patients treated with SLK achieved HiSCR75 response and up to 32% of patients achieved HiSCR100 response at Week 40 (as observed). The results were consistent across both trials (VELA-1: 61.9% HiSCR75, 32.4% HiSCR100; VELA-2: 61.8% HiSCR75, 28.1% HiSCR100; as observed). Up to 77% of patients achieved an IHS-4 55 response (VELA-1: 74.3%, VELA-2: 77.4%; as observed) and up to 25% of patients achieved inflammatory remission at Week 40 (A100 + DT100 + N100; VELA-1: 25.2%, VELA-2: 21.1%; as observed).

With 62% of SLK patients reaching a HiSCR75 response already at Week 40, SLK sets a new standard in long-term lesion control of HS. Approved IL-17A and IL17A & F inhibitors reported HiSCR75 response rates of approximately 40% and 60%, respectively, at the 1-year mark of their respective pivotal trials (approved doses, pooled analysis across pivotal trials).

The strong long-term clinical responses were accompanied by continued improvement in PROs, which reflect critical quality of life outcomes for patients with HS. Patients treated with SLK showed a significant improvement of HiSQOL score at Week 40 with a -11.8 change from baseline in VELA-1, and -12.4 change from baseline in VELA-2 (mean HiSQOL at baseline of 26.5 (VELA-1) and 28.0 (VELA-2); as observed). While 59% of patients were within the “very severe” category on the HiSQOL severity score at baseline, 63% of patients were in the “mild / none” category at Week 40 (as observed, pooled). Improvements versus baseline in HiSQOL-Mini items ranged from 41% (pain), to 54% (walking, getting dressed) to 62% (down or depressed) at Week 40 (in patients with baseline >0, as observed, pooled). In addition, up to 43% of patients experienced a marked reduction of pain, as measured by an at least 3-point improvement from baseline in the worst skin pain NRS (VELA-1: 43.2%, VELA-2: 37.2%; as observed, baseline score of at least three points). 65% of patients achieved a meaningful (at least four points from baseline) improvement in DLQI (VELA-1: 64.6%, VELA-2: 65.3%; as observed, baseline DLQI of at least four points).

The safety profile of SLK in the VELA clinical trials remains consistent over time, with no new safety signals detected.

Prof. Alexa Kimball, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Professor of Dermatology at Harvard Medical School said: “The Week 40 results from the VELA trials show an early and increasing clinical benefit over time for patients treated with sonelokimab, addressing a critical goal in HS treatment: long-term disease control. The consistency of the VELA data over time reinforces the opportunity for sonelokimab to address this important unmet need for patients living with HS.”

Details of the Week 40 results from Phase 3 VELA clinical trials in HS will be presented by Prof. Alexa Kimball at the 2026 AAD Annual Meeting (S034 Late-Breaking Research: Session 2). The presentation titled Sonelokimab in Moderate-to-Severe HS: Long-term Results through Week 40 of Two Phase 3 Trials will be on March 28, 2026 at 4pm – 4.12pm ET (2pm – 2.12pm MT).

Important upcoming anticipated milestones for MoonLake:  

  • Q2 2026: 52-week data of the VELA-1 and VELA-2 trials in HS
  • Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA
  • H2 2026: Submission of a BLA for HS
  • H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA

-Ends-

MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com.

About Nanobodies®Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.

The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.

About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).

For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p