MoonLake Immunotherapeutics (MLTX), a clinical-stage biotechnology company, on Monday announced positive 52 week results from the Phase 3 registrational VELA-1 and VELA-2 clinical trials evaluating Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa. In addition, the company provided an update about the upcoming milestones.
Following the news, MLTX is up 10.26% at $21.18 in the overnight market.
Hidradenitis Suppurativa or HS is a chronic inflammatory skin disease that can lead to painful lesions, scarring and irreversible tissue damage in severe cases.
Company Profile
MoonLake focuses on developing nanobody therapies for inflammatory diseases, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis.
Sonelokimab is the company's lead investigational 40-kDa humanised nanobody, consisting of three VHHs covalently linked by flexible glycine-serine spacers, for the treatment of inflammatory disease. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA). In addition, the company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).
Trial Details
The Phase 3 VELA program consists of VELA-1 and VELA-2, and both are global, randomised, double-blind, and placebo-controlled trials that are identical in design, evaluating the efficacy and safety of Sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. The program together enrolled a total of 838 patients.
The primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a higher than or equal to 75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline.
Under the secondary endpoints the trial evaluated, the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of equal to more than 4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient's Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100).
Key Findings
-At Week 52, Sonelokimab showed consistent further improvement across all clinical scores compared with the Week 16 data.
-Notably, 67.2% of patients treated with Sonelokimab achieved HiSCR75 across both VELA-1 and VELA-2. -33.1% of patients achieved HiSCR100 at Week 52.
-26.0% of patients achieved an IHS4-100 response (VELA-1: 24.4%, VELA-2: 27.7%), reflecting inflammatory remission.
-Numerically higher long-term efficacy than previously reported Phase 3 results for competing IL-17 therapies in cross-trial comparisons.
-The safety profile of Sonelokimab in the VELA clinical programs remains consistent over time, with no new safety signals detected, said the company.
Upcoming Milestones
Submission of the Biologics License Application (BLA) for Sonelokimab in HS, including data from adolescent patients, is expected at the end of September 2026.
Following the planned September 2026 BLA submission, the company expects FDA filing acceptance and review designation around November 2026.
In addition, in mid-2026, the company expects the primary endpoint readout from the Phase 3 IZAR-1 trial of Sonelokimab in psoriatic arthritis.
In the second half of 2026, the primary endpoint readout of the Phase 3 IZAR-2 trial in PsA is anticipated.
In the second half of 2026, the company expects an interim readout of the Phase 2 P-OLARIS trial in PsA and axSpA.
The company has scheduled an investor day webcast today, from 8:00 - 9:30 a.m. EST to discuss these data and provide guidance on upcoming events.
MLTX closed Thursday's (18-06-2026) trade at $19.21, up 0.10%.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.