MoonLake Immunotherapeutics Announces Week 16 Results from VELA Phase 3 Hidradenitis Suppurativa Program Evaluating Nanobody® Sonelokimab

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MoonLake Immunotherapeutics announced Phase 3 VELA program results for sonelokimab in moderate to severe hidradenitis suppurativa (HS). The combined trials showed statistically significant improvements in primary and key secondary endpoints. VELA-1 achieved statistical significance, while VELA-2 missed its primary endpoint due to a higher placebo response. Both trials showed noteworthy HiSCR75 results using a pre-specified treatment policy strategy. Sonelokimab exhibited a favorable safety profile. MoonLake plans regulatory discussions and continues clinical studies in multiple indications.

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MoonLake Immunotherapeutics (NASDAQ: MLTX) recently unveiled week 16 results from its Phase 3 VELA program, a study evaluating the efficacy of sonelokimab in treating moderate to severe hidradenitis suppurativa (HS). The combined data from the trials demonstrated statistically significant improvements across all primary and key secondary endpoints (p

In the VELA-1 trial, sonelokimab achieved statistical significance, showcasing a 17% delta compared to the placebo group (p9% delta, statistical significance was not reached (p=0.053) due to a higher-than-anticipated placebo response. Utilizing a pre-specified treatment policy strategy, both trials reported noteworthy HiSCR75 results at week 16, revealing response rates of 35% and 36% for sonelokimab, against placebo rates of 18% and 26%, respectively.

Importantly, the drug exhibited a favorable safety profile, revealing no new safety-related concerns, including the absence of suicidal ideation and behavior. MoonLake plans to engage with regulatory bodies to define the optimal path toward registration, while also continuing clinical studies in multiple indications.

MoonLake Immunotherapeutics (NASDAQ: MLTX) ha riportato i risultati della settimana 16 dal suo programma di fase 3 VELA che testa sonelokimab in idradenite suppurativa moderata-severa (HS). I trials combinati hanno miglioramenti statisticamente significativi su tutti gli endpoint primari e secondari chiave (p

In VELA-1, sonelokimab ha raggiunto significatività statistica con uno delta del 17% rispetto al placebo (pdelta del 9% ma non ha raggiunto la significatività statistica (p=0,053) a causa di una risposta al placebo superiore alle aspettative. Usando la strategia di policy di trattamento, entrambi gli studi hanno ottenuto HiSCR75 significativo alla settimana 16, con tasso di risposta di sonelokimab del 35% e 36% contro i tassi di placebo del 18% e 26% rispettivamente.

Il farmaco ha mostrato un profilo di sicurezza favorevole senza nuove segnali di sicurezza, inclusa l’assenza di ideazione e comportamento suicidari. L’azienda cercherà indicazioni regolatorie per il percorso verso la registrazione, continuando nel contempo altri studi clinici in diverse indicazioni.

MoonLake Immunotherapeutics (NASDAQ: MLTX) informó resultados de la semana 16 de su programa de fase 3 VELA que evalúa sonelokimab en hidradenitis suppurativa (HS) de moderada a severa. Los ensayos combinados mostraron mejoras estadísticamente significativas en todos los endpoints primarios y secundarios clave (p

En VELA-1, sonelokimab logró significancia estadística con un delta del 17% respecto al placebo (pdelta del 9% pero no alcanzó significancia estadística (p=0.053) debido a una respuesta al placebo más alta de lo esperado. Utilizando la estrategia de política de tratamiento, ambos ensayos lograron HiSCR75 significativo en la semana 16, con tasas de respuesta de sonelokimab de 35% y 36% frente a las tasas de placebo de 18% y 26% respectivamente.

El fármaco demostró un perfil de seguridad favorable sin nuevas señales de seguridad, incluida la ausencia de ideación y comportamiento suicidas. La empresa buscará orientación regulatoria para el camino hacia el registro, mientras continúa otros estudios clínicos en múltiples indicaciones.

MoonLake Immunotherapeutics (NASDAQ: MLTX)가 중등도에서 중증의 여드름성 발진(Hidradenitis Suppurativa, HS)에서 소넬로키맙을 시험하는 3상 VELA 프로그램의 16주 차 결과를 발표했습니다. 결합된 연구는 주요 1차 및 주요 2차 종결점에서 통계적으로 유의한 개선을 보였습니다(p

VELA-1에서 소넬로키맙은 위약 대비 17% 차이로 통계적 유의성을 달성했습니다(p9% 차이를 보였으나 통계적 유의성은 놓쳤다 (p=0.053) 높아진 위약 반응으로 인해. 치료 정책 전략을 사용하여 두 연구 모두 16주 차에 HiSCR75의 유의미한 결과를 얻었으며, 소넬로키맙의 반응률은 각각 35%와 36%로 위약의 18% 및 26%에 비해 높았습니다.

약물은 안전성 프로파일이 우수하며 새로운 안전 신호는 없었고 자살 사상 및 행동의 부재를 포함합니다. 회사는 등록 경로에 대한 규제 지침을 구하고, 여러 적응증에서 다른 임상 연구를 계속할 예정입니다.

MoonLake Immunotherapeutics (NASDAQ: MLTX) a publié les résultats de la semaine 16 de son programme de Phase 3 VELA évaluant le sonelokimab dans l’hidradénite suppurée (HS) modérée à sévère. Les essais combinés ont obtenu des améliorations statistiquement significatives sur tous les critères primaires et secondaires clés (p

Dans VELA-1, le sonelokimab a atteint une signification statistique avec un delta de 17% par rapport au placebo (pdelta de 9% mais a manqué de significativité statistique (p=0,053) en raison d’une réponse au placebo plus élevée que prévu. En utilisant la stratégie de politique de traitement, les deux essais ont obtenu un HiSCR75 significatif à la semaine 16, avec des taux de réponse de sonelokimab de 35% et 36% contre des taux de placebo de 18% et 26% respectivement.

Le médicament a démontré un profil de sécurité favorable sans nouveaux signaux de sécurité, y compris l’absence d’idéation et de comportement suicidaire. L’entreprise sollicitera des conseils réglementaires sur le chemin de l’enregistrement tout en poursuivant d’autres études cliniques dans plusieurs indications.

MoonLake Immunotherapeutics (NASDAQ: MLTX) hat Woche-16-Ergebnisse aus seinem Phase-3-VELA-Programm veröffentlicht, das Sonelokimab bei mäßiger bis schwerer Hidradenitis suppurativa (HS) untersucht. Die kombinierten Studien zeigten statistisch signifikante Verbesserungen in allen primären und wichtigen sekundären Endpunkten (p

In VELA-1 erreichte Sonelokimab statistische Signifikanz mit einem Delta von 17% gegenüber Placebo (pDelta von 9%, verfehlte jedoch die statistische Signifikanz (p=0,053) aufgrund einer stärker als erwartet ausfallenden Placebo-Reaktion. Unter Anwendung der Behandlungs-Policy-Strategie erzielten beide Studien zu Woche 16 signifikante HiSCR75, wobei Sonelokimab eine 35% bzw. 36%-Antwortrate gegenüber Placebo von 18% bzw. 26% zeigte.

Das Medikament zeigte ein besonders günstiges Sicherheitsprofil mit keinen neuen Sicherheitszeichen, einschließlich dem Fehlen von suizidalen Gedanken und Verhaltensweisen. Das Unternehmen wird regulatorische Hinweise zum Weg zur Zulassung einholen und gleichzeitig weitere klinische Studien in mehreren Indikationen fortsetzen.

MoonLake Immunotherapeutics (NASDAQ: MLTX) أبلغت عن نتائج الأسبوع 16 من برنامج المرحلة 3 VELA الذي يختبر سونيليوكيماب في الهيدريدنيتس سوتورا (HS) من المعتدل إلى الشديد. أظهرت التجارب المجمعة تحسينات ذات دلالة إحصائية في جميع النقاط الأولية والثانوية الرئيسية (p

في VELA-1، حقق سونيليوكيماب دلالة إحصائية بفارق 17% عن الدواء الوهمي (pفارقًا بمقدار 9% لكنه فشل في الوصول إلى الدلالة الإحصائية (p=0.053) بسبب استجابة الدواء الوهمي أعلى من المتوقع. باستخدام استراتيجية سياسة العلاج، حققت كلا التجربتين HiSCR75 معنوية في الأسبوع 16، مع نسب استجابة سونيليوكيماب تبلغ 35% و36% مقابل نسب الدواء الوهمي 18% و26% على التوالي.

أظهر الدواء ملف أمان ملائم بدون إشارات أمان جديدة، بما في ذلك غياب الأفكار والسلوك الانتحاري. ستسعى الشركة للحصول على توجيهات تنظيمية لمسار التسجيل مع مواصلة دراسات سريرية أخرى في عدة مؤشرات.

MoonLake Immunotherapeutics (NASDAQ: MLTX) 公布了其第三阶段 VELA 计划在中度至重度化脓性汗腺炎（HS）中对 sonelokimab 的第16周结果。合并试验在所有主要和关键次要终点上显示了统计学意义的显著改善（p

在 VELA-1 中，sonelokimab 实现了相对于安慰剂的 17% 差异的统计显著性（p9% 的差异，但未达到统计显著性（p=0.053），原因是安慰剂反应水平高于预期。采用治疗策略的政策，两项试验在第16周均达到显著的 HiSCR75，sonelokimab 的反应率分别为 35% 和 36%，相比安慰剂的 18% 和 26% 水平。

该药物显示出良好的安全性特征，未发现新的安全信号，包括无自杀意念和行为。公司将寻求监管方面的指导以推进注册路径，同时在多种适应症上继续开展其他临床研究。

Positive

  • Statistically significant improvements across all primary and key secondary endpoints in combined VELA program
  • Strong efficacy in VELA-1 with 17% delta to placebo (p
  • Consistent sonelokimab response rates between trials (35% and 36%)
  • Favorable safety profile with no new safety signals
  • Convenient dosing scheme with monthly maintenance after initial induction phase

Negative

  • VELA-2 missed statistical significance in primary endpoint using composite strategy (p=0.053)
  • Higher than expected placebo response in VELA-2 (26% vs historical 13-18%)
  • Regulatory path forward needs confirmation following mixed trial results

Insights

MoonLake reports mixed Phase 3 results with sonelokimab showing statistical significance in one trial but missing primary endpoint in second trial.

MoonLake’s Phase 3 VELA program testing sonelokimab in hidradenitis suppurativa has delivered mixed results at the week 16 primary endpoint. The data shows a tale of two trials – with VELA-1 meeting all endpoints while VELA-2 missed statistical significance on its primary endpoint due to a higher-than-expected placebo response.

The company used an ambitious primary endpoint of HiSCR75 (75% reduction in inflammatory lesions), which is more stringent than the HiSCR50 typically used in competitor trials. Using the pre-specified treatment policy analysis, sonelokimab achieved 34.8% and 35.9% HiSCR75 responses in VELA-1 and VELA-2 respectively, compared to placebo responses of 17.5% and 25.6%. The unexpectedly high placebo response in VELA-2 prevented statistical significance under the primary composite strategy (p=0.053).

When analyzing both trials combined, sonelokimab demonstrated clinically meaningful and statistically significant improvements across all endpoints (pcluding quality-of-life measures and pain reduction. The safety profile remains favorable with no new safety signals detected. The most common side effect was oral candidiasis (yeast infection) in 7.3% of treated patients versus 0.4% on placebo.

With a convenient dosing regimen (induction with 4 injections followed by monthly maintenance), MoonLake will now discuss regulatory pathways forward. The company’s focus on demonstrating efficacy using a higher threshold (HiSCR75) was ambitious but creates complexity for regulatory submission given the mixed VELA-2 results. The study continues to the pre-specified week 52 readout, and MoonLake’s broader pipeline includes trials in psoriatic arthritis, adolescent HS, palmoplantar pustulosis, and axial spondyloarthritis with readouts expected through 2026.

MoonLake reports mixed Phase 3 results with statistical success in combined analysis but VELA-2 missed primary endpoint with high placebo response.

MoonLake’s Phase 3 sonelokimab results reveal a promising but complicated path forward for their lead asset. The company chose a more stringent primary endpoint (HiSCR75) than typically used in competitive trials, which demonstrates scientific confidence but increases regulatory risk. This strategy delivered mixed results – with VELA-1 achieving statistical significance across all endpoints while VELA-2 stumbled at the primary endpoint due to unexpected placebo performance.

The efficacy of sonelokimab itself appears consistent between trials (34.8% and 35.9% HiSCR75), but the placebo response in VELA-2 (25.6%) greatly exceeded historical norms of 13-18%. This placebo variability creates regulatory uncertainty despite the combined analysis showing statistical significance.

Beyond the headline results, sonelokimab demonstrated consistent improvements in critical patient-reported outcomes including the HiSQOL quality-of-life measure and pain NRS scores. Nearly 60% of patients achieved meaningful improvements in quality of life (DLQI). The drug’s safety profile remains competitive with oral candidiasis as the most notable treatment-emergent adverse event.

MoonLake’s catalyst timeline remains robust with five additional readouts expected through H1 2026 across multiple inflammatory indications. The company plans regulatory discussions to determine if the combined analysis and secondary endpoint successes can support approval despite the VELA-2 primary endpoint miss. Investors should note that even with successful regulatory discussions, commercial launch would likely be delayed compared to previous expectations. The complete 52-week data expected in Q2 2026 will provide additional efficacy and safety information that may strengthen the regulatory case.

09/28/2025 – 12:04 PM

  • VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16
  • Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treatment policy strategy to test the robustness of the results: difference between the two methods relates to the statistical handling of intercurrent events
  • In the combined VELA program, patients treated with sonelokimab experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p
  • In VELA-1, sonelokimab achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p
  • In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053)
  • The pre-specified treatment policy strategy provides for the analysis of data irrespective of intercurrent events; using this analysis, a statistically significant HiSCR75 at week 16 in VELA-1 and VELA-2 was achieved with sonelokimab (35% and 36%, respectively) vs placebo (18% and 26%, respectively); clinically meaningful and statistically significant benefit was also observed for all key secondary endpoints (Table 2)
  • Sonelokimab continued to show a favourable safety profile with no new safety signals detected, including an absence of key events of interest such as suicidal ideation and behavior
  • VELA progresses to its pre-specified week 52 readout and the Company will now seek to confirm the path to registration in HS with the appropriate regulatory authorities
  • Other clinical studies with sonelokimab, including the Phase 3 VELA-TEEN trial in adolescent HS, the Phase 3 IZAR program and the Phase 2 P-OLARIS trial in psoriatic arthritis (PsA), the Phase 2 LEDA trial in palmoplantar pustulosis (PPP), and the Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA), continue as planned and are expected to support a catalyst-rich roadmap
  • The Company will hold a webcast on Monday, September 29 at 2pm CET / 8am EDT (link below)

ZUG, Switzerland, September 28, 2025 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the week 16 results of the Phase 3 VELA-1 and VELA-2 trials of its registrational global program in patients with moderate-to-severe hidradenitis suppurativa (HS).

The VELA program 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 percentage of participants achieving HiSCR50 and the percentage of patients achieving a Dermatology Quality of Life Index (DLQI) total score reduction of >4 (minimal clinically important difference), among participants with a baseline DLQI >4, 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 pain Numerical Rating Scale (NRS) among participants with a baseline score of at least 3 points, and the change from baseline in the HS-specific Quality of Life score (HiSQOL). A total of 838 patients were enrolled across both trials. The trials were identical in design comparing a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. From week 16, all patients receive the 120mg dose of sonelokimab through to 48 weeks, with a last assessment at week 52, followed by an open-label extension for up to two years. The Phase 3 program used a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS. The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. Data in this press release is presented using the aforementioned analysis strategies, as indicated throughout. The baseline characteristics for VELA-1 and VELA-2 are shown in Table 1.

TABLE 1

Baseline Characteristics Trials
VELA 1 VELA 2
Placebo
(n=138)		 SLK
(n=283)		 Placebo
(n=141)		 SLK
(n=276)
Age [years], mean 36.1 37.2 38.0 37.2
Female, % 62.3 61.5 49.6 53.6
Race, %
White
Black or African American 		76.1
15.2		 77.7
12.0		 85.1
10.6		 81.5
9.4
BMI, mean 33.6 33.5 32.7 33.0
Current smoker, % 41.3 43.8 56.0 51.8
Hurley Stage, %
II
III 		63.8
36.		 64.0
36.0		 67.4
32.6		 63.0
37.0
Years since diagnosis, mean 8.4 8.1 7.7 7.5
Lesions, mean
AN count
DT count 		13.3
2.8		 13.5
3.2		 13.8
3.5		 14.5
3.9
DLQI Total, mean 11.8 11.7 11.3

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