sonelokimab (M1095) / EMD Serono, Avillion, MoonLake Immunotherap - LARVOL DELTA

Proteomic analyses in the Phase 2 ARGO trial identify IL 17 signaling-associated markers linked to disease activity, treatment response to sonelokimab, and pharmacodynamic changes in psoriatic arthritis (ACR Convergence 2026) - P2 | "Pearson correlation analysis sought to identify proteins significantly (nominal P< 0.05) associated with (a) BL disease severity across skin (PASI), joints (SJC66), and systemic inflammation (hs-CRP), and (b) treatment responses to SLK (pooled 60 mg and 120 mg with induction [WI] doses) and adalimumab (ADA; reference arm) at W12. Proteomic profiling in ARGO highlighted a central role of IL‑17 signaling across PsA tissue domains, with IL-17F levels correlating with both skin and joint severity. The IL-17 responsive markers IL-19 and PI3 correlated with SLK treatment responses and were reduced following SLK, but not ADA, treatment. Overall, these data provide evidence for the mechanistic rationale of inhibiting IL-17F, as well as IL-17A, across multiple tissue domains."

P2 data • PK/PD data • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • ALDH3A1 • CRP • IL17A • IL17C • IL6

IL-17 Pathway Inhibitors in Psoriatic Arthritis: A Systematic Review and Network Meta-analysis of Efficacy, Safety, Treatment Rankings, and Certainty of Evidence (ACR Convergence 2026) - "Secukinumab, ixekizumab, and bimekizumab formed the primary network; sonelokimab and izokibep were evaluated in exploratory analyses; adalimumab served as a bridge comparator. IL-17 pathway inhibitors are effective short-term treatments for active PsA, with consistent benefits across joint, skin, multidomain, and functional outcomes. Within-class rankings suggest possible differences, but overlapping confidence intervals and reliance on indirect comparisons preclude definitive superiority claims. Candida risk, particularly with dual IL-17A/F inhibition, and patient-specific factors should inform individualised treatment selection."

Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Dual IL-17A/IL-17F Inhibition Modulates Entheseal Stromal Inflammatory Networks and Reveals a Role for IL-17F in Neutrophil Recruitment in Human Entheseal Inflammation (ACR Convergence 2026) - "This study explores the impact IL-17F has on entheseal inflammation and, by utilizing sonelokimab (SLK)-a nanobody that binds both IL-17A and IL-17F with similarly high affinity designed for superior penetration into tissues such as entheses-highlights a role for IL-17F in stromal-mediated neutrophil activation and IL-17 signalling redundancy...Soft tissue stromal cells were treated with TNF, IL-17A and IL-17F with or without SLK (165 nM) or secukinumab (SEC; 165 nM)... In this study, SLK was associated with broader modulation of entheseal stromal inflammatory networks than SEC, suggesting dual IL-17A/IL-17F blockade may allow greater control of entheseal inflammation than IL-17A blockade alone. This was accompanied by reduced expression of neutrophil‑relevant mediators and decreased neutrophil activity with SLK blockade. High IL‑17F expression under inflammatory conditions may support pathway redundancy that sustains IL‑17-driven inflammation when IL‑17A alone is..."

Stroma • Ankylosing Spondylitis • Inflammation • Inflammatory Arthritis • Psoriasis • Seronegative Spondyloarthropathies • Spondylarthritis • ELANE • IL17A • IL1B • IL23A

IZAR-1: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (clinicaltrials.gov) - P3 | N=960 | Active, not recruiting | Sponsor: MoonLake Immunotherapeutics AG | Trial primary completion date: Feb 2027 ➔ May 2026

Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IZAR-1: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (clinicaltrials.gov) - P3 | N=960 | Not yet recruiting | Sponsor: MoonLake Immunotherapeutics AG

New P3 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IZAR-1: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (clinicaltrials.gov) - P3 | N=960 | Active, not recruiting | Sponsor: MoonLake Immunotherapeutics AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IZAR-1: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (clinicaltrials.gov) - P3 | N=960 | Recruiting | Sponsor: MoonLake Immunotherapeutics AG | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IZAR-2: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: MoonLake Immunotherapeutics AG | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Sep 2027

Enrollment closed • Trial completion date • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IZAR-2: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: MoonLake Immunotherapeutics AG | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

IZAR-2: Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: MoonLake Immunotherapeutics AG

New P3 trial • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Nanobody-Based Therapeutics in Inflammatory Skin Diseases: Emerging Clinical Targets and Future Directions (EADV 2026) - "Sonelokimab has demonstrated promising efficacy in psoriasis and hidradenitis suppurativa, supporting IL-17A/F blockade as a relevant nanobody-based strategy in skin inflammation. Lunsekimig and brivekimig illustrate the potential of multispecific nanobody constructs targeting complementary inflammatory pathways, particularly in atopic dermatitis and hidradenitis suppurativa...Their small size, high specificity, and capacity for multispecific engineering support their promise as next-generation targeted biologic platforms. Although current evidence remains preliminary, further translational and clinical studies are necessary to better define their efficacy, safety, and future role in the treatment of inflammatory skin diseases."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Inflammation • Inflammatory Arthritis • Lupus • Psoriasis • Systemic Lupus Erythematosus • IL13 • IL17A • IL6R • TNFA • TNFSF4 • TSLP

High levels of pain response with sonelokimab in VELA-1 and VELA-2: two Phase 3 trials in patients with moderate-to-severe HS (EADV 2026) - P2, P3 | "Sonelokimab demonstrated a favorable safety profile across all HS trials, with no new safety signals. Conclusions These results support sonelokimab as a promising potential new treatment option that can meaningfully and rapidly reduce pain for patients with moderate-to-severe HS."

Clinical • P3 data • Pain • IL17A

Responses to sonelokimab are robust following prior exposure to biologics in patients with moderate-to-severe HS: pooled analysis of the VELA-1 and VELA-2 Phase 3 trials (EADV 2026) - P2, P3 | "Adalimumab accounted for the vast majority of prior TNFi treatment, while secukinumab was the most common non-TNFi prior biologic. Conclusions Sonelokimab achieved robust and clinically meaningful responses at Week 16 in patients with prior biologic exposure, including prior TNFi, with outcomes comparable to the overall population. These findings support sonelokimab as a promising potential new treatment option for moderate-to-severe HS, irrespective of prior biologic history."

P3 data • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A • IL17RA

Sonelokimab in moderate-to-severe HS: clinically meaningful IHS4 outcomes from the Phase 3 VELA-1 and VELA-2 trials (EADV 2026) - P3 | "Sonelokimab also demonstrated a favorable safety profile. Conclusions These results support sonelokimab as a promising potential new treatment option for moderate-to-severe HS."

Clinical • P3 data • Acne Vulgaris • Dermatology • Dermatopathology • Hidradenitis Suppurativa • Immunology • IL17A

HiSQOL outcomes are rapidly improved with sonelokimab in the Phase 3 VELA-1 and VELA-2 trials: HS-specific quality-of-life scores in patients with moderate-to-severe HS (EADV 2026) - P2, P3 | "Sonelokimab demonstrated a favorable safety profile across all HS trials, with no new safety signals. Conclusions These results support sonelokimab as a promising potential new treatment option to improve symptoms and quality of life for patients with moderate-to-severe HS."

Clinical • HEOR • P3 data • Acne Vulgaris • Dermatology • Dermatopathology • Hidradenitis Suppurativa • Immunology • IL17A

Decoding the IL-17 axis in hidradenitis suppurativa: Pharmacodynamic profiling of the Nanobody sonelokimab reveals IL-19 and PI3 as biomarkers of IL-17 pathway activity (EADV 2026) - P2 | "Protein levels were measured at baseline and after 12 weeks of sonelokimab, placebo, or adalimumab treatment to assess pharmacodynamic responses. Conclusions IL-19 and PI3 are robust pharmacodynamic IL-17 pathway biomarkers of disease activity in HS. Their normalization following sonelokimab treatment underscores the drug's targeted mechanism of action and supports their potential utility in monitoring therapeutic response, further validating IL-17A and IL-17F as central drivers of HS pathogenesis."

Biomarker • PK/PD data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Sonelokimab, a novel IL-17A- and IL-17F-inhibiting Nanobody, in moderate-to-severe palmoplantar pustulosis: Efficacy, safety, and translational results from the open-label Phase 2 LEDA trial (EADV 2026) - "Safety was consistent with prior studies, with no new signals. These findings support further investigation of IL‑17A and IL‑17F inhibition with the Nanobody sonelokimab as a potential therapeutic approach for PPP."

Clinical • P2 data • Candidiasis • CNS Disorders • Depression • Immunology • Psoriasis • Suicidal Ideation • CXCL6 • IL17A

Sonelokimab reduces lesion drainage in patients with moderate-to-severe HS: pooled analysis of the VELA-1 and VELA-2 Phase 3 trials (EADV 2026) - P2, P3 | "Data were analyzed using modified non-responder imputation (intention-to-treat cohort), adjusted for stratification factors. LS, least squares."

P3 data • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Sonelokimab, a novel IL-17A- and IL-17F-inhibiting nanobody for the treatment of moderate-to-severe hidradenitis suppurativa: a global, randomized, double-blind, placebo-controlled phase 2 clinical trial (MIRA). (PubMed, J Am Acad Dermatol) - "Sonelokimab demonstrated high levels of clinical response in patients with moderate-to-severe HS and was well tolerated."

Clinical • Journal • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IL17A

On September 30, 2026, MoonLake Immunotherapeutics (the ’Company’) submitted a Biologics License Application (’BLA’) to the U.S. Food and Drug Administration (’FDA’), seeking approval of its tri-specific nanobody sonelokimab for the treatment of moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older (StockTitan.net) - "The Company expects to be notified by the FDA whether the BLA submission is accepted for review within approximately 60 days of submission, and to receive the planned review timeline within approximately 74 days of submission."

FDA filing • Hidradenitis Suppurativa • Immunology

IL-17 ligand-targeting inhibitors in psoriatic arthritis: a focused systematic review and network meta-analysis of efficacy, safety, and certainty of evidence. (PubMed, Front Immunol) - "Ixekizumab Q2W had the highest ACR50 P-score, followed by bimekizumab 160 mg with loading and ixekizumab Q4W; however, active-treatment confidence intervals overlapped...Sonelokimab and izokibep showed favorable exploratory estimates but very low certainty...The protocol was registered in PROSPERO (CRD420251156756). https://www.crd.york.ac.uk/PROSPERO/view/CRD420251156756, identifier CRD420251156756."

Clinical • Journal • Retrospective data • Review • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Important upcoming anticipated milestones for MoonLake (The Manila Times) - "HS: End Sep. 2026: Expected submission of Biologics License Application (BLA); End Nov. 2026: Expected to receive Prescription Drug User Fee Act (PDUFA) date allocation and decision on Priority Review."

FDA filing • PDUFA • Hidradenitis Suppurativa • Immunology

Systemic Treatment of Psoriasis: Current Evidence on Efficacy and Safety. (PubMed, J Dermatol) - "Older conventional systemic agents, such as cyclosporin, acitretin, or methotrexate, remain useful in selected settings, especially when treatment options are limited by cost or availability, when short-term disease control is needed, or when the patient prefers these treatments...Biologics targeting TNF-α or anti-IL-12/23p40 ustekinumab have established the biologic treatment era, and remain clinically relevant, especially for patients having psoriatic arthritis or prioritizing long-term safety...Targeted oral therapies increase options for patients who prefer non-injectable treatment; established or emerging agents include apremilast, deucravacitinib, icotrokinra, zasocitinib, envudeucitinib, and orismilast. Emerging IL-17-directed agents, including sonelokimab and izokibep, may further refine pathway targeting. Selection of treatment should be decided dependently on the completeness of skin clearance achieved, speed and duration of responses, effectiveness on..."

Journal • Review • Candidiasis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • TNFA

MoonLake Announces Positive Topline Results from the Phase 3 IZAR-1 Trial of Sonelokimab in Psoriatic Arthritis Demonstrating Significant Improvements Across all Clinical Endpoints… (The Manila Times) - "A total of 42.1% of biologic-naïve patients treated with sonelokimab 60 mg with induction achieved an ACR50 response. In addition, sonelokimab demonstrated strong efficacy across multiple disease domains characteristic of PsA. Across key secondary clinical endpoints, 66.5% of patients achieved ACR20, and 41.2% achieved MDA at Week 16. In patients with concomitant skin involvement, 61% achieved PASI90 at Week 16. Patients treated with sonelokimab also demonstrated clinically meaningful improvements in patient-reported and physical outcomes....The IZAR-1 trial remains blinded and will continue until Week 52 with MoonLake expecting the full readout in H1 2027 whereas the IZAR-2 trial (a trial in TNF-refractory patients) is expected to complete enrollment in Q3 2026."

Enrollment status • P3 data: top line • Immunology • Psoriatic Arthritis

Decoding Biological Drug Names in Dermatology: The Post-2022 WHO Nomenclature Revision and Its Implications for Clinical Practice. (PubMed, J Am Acad Dermatol) - "The post-2022 structural stems carry direct pharmacokinetic implications, and two currently used agents (sonelokimab and certolizumab pegol) are structurally misclassified under their legacy -mab names. Nomenclature literacy directly affects adverse event attribution, biosimilar substitution decisions, and pipeline evaluation. Understanding this evolving system is a patient safety competency for practicing dermatologists."

Journal • Review • Dermatology • Oncology • TYK2