MoonLake Immunotherapeutics (MLTX) announced on March 28, 2026, the Week 40 results from its Phase 3 VELA programs in hidradenitis suppurativa, showing that clinical responses continued to improve well beyond the initial 16-week primary endpoint.
Hidradenitis suppurativa (HS) is a chronic, painful inflammatory skin disease marked by recurring abscesses, nodules, and draining tunnels- often leading to scarring and significant quality-of-life impairment. Treatment options remain limited, and long-term disease control is a major unmet need for patients and physicians.
Phase 3 VELA Program Overview
The VELA-1 and VELA-2 trials enrolled 838 adults with moderate-to-severe HS. Both were global, randomized, double-blind, placebo-controlled studies evaluating Sonelokimab (SLK), a Nanobody that targets IL-17A and IL-17F. -Primary endpoint: HiSCR75 at Week 16 defines a response as an at least 75% reduction in abscess and inflammatory nodules with no worsening of abscess or draining tunnels.
-Key secondary endpoints: HS Quality of Life score (HiSQOL), IHS4-55, skin pain (NRS), and Dermatology Quality of Life Index (DLQI).
After Week 16, placebo-treated patients were switched to SLK through Week 52, while those originally on SLK continued monthly dosing.
Week 40 Results: Continued Improvement Over Time
MoonLake reported that 62% of patients treated with SLK achieved HiSCR75, and up to 32% achieved HiSCR100- complete resolution of abscesses and inflammatory nodules. Results were consistent across both trials.
Additional findings included:
-Up to 25% of patients reached inflammatory remission (A100+N100+DT100).
-Up to 77% achieved IHS4-55, another measure of substantial disease improvement.
-Quality-of-life gains were notable, with HiSQOL scores improving by 12 points on average, shifting most patients from "very severe" at baseline to "mild/none" by Week 40.
-Pain reductions were meaningful, with up to 43% achieving at least a 3-point improvement in worst skin pain.
-DLQI improvements of at least 4 points were seen in 65% of patients.
No new safety signals were observed, and discontinuation rates remained low.
Expert Commentary
Prof. Alexa Kimball of Harvard Medical School noted that the Week 40 results demonstrate "early and increasing clinical benefit over time," reinforcing Sonelokimab's potential to address long-term disease control in HS.
Upcoming Milestones MoonLake highlighted several anticipated readouts:
-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 psoriatic arthritis (PsA).
-H2 2026: Submission of a BLA for HS.
-H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA.
MLTX has traded between $5.95 and $62.75 over the past year. The stock closed Friday's trading (March 27, 2026) at $17.32, up 2.42%. In pre-market trading the stock is at $17.76, up 2.54%.
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