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

Assessing the clinical progress of the bispecific nanobody sonelokimab. (PubMed, Expert Opin Investig Drugs) - "Its nanobody-based structure enables deeper tissue penetration and better disease control. Further phase 3 trials and head-to-head studies are crucial to establish its long-term efficacy and safety, potentially positioning it as a leading therapeutic option."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Pain • Pruritus • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

MoonLake Immunotherapeutics to host a Capital Markets Day on Tuesday, April 29 (GlobeNewswire) - "MoonLake's CEO, Jorge Santos da Silva, CSO, Kristian Reich and CFO, Matthias Bodenstedt will share information on key financial and clinical updates....Following the conclusion of patient recruitment of the VELA program with the Nanobody sonelokimab in HS, the management team will share details on the baseline characteristics of the trial and its comparability to Phase 2 MIRA and other competitor trials, as well as narrowed guidance with respect to the timing of the primary endpoint read-out....An earlier-than-expected interim readout of the LEDA study, highlighting the potential of sonelokimab in the evolving PPP market and further derisking the overall development of the asset."

Trial status • Hidradenitis Suppurativa • Immunology • Inflammation

MoonLake Secures up to $500 Million in Non-Dilutive Financing from Hercules Capital and Announces a Capital Markets Update on April 29 to Provide Important Clinical Updates (GlobeNewswire) - "Facility adds to the $448 million cash position disclosed in previously filed 10-K and provides funding for the next steps of the Company’s growth, including the expected launch of sonelokimab in 2027, additional clinical trials and further investments for growth....MoonLake Immunotherapeutics...announced that it has entered into an agreement with Hercules Capital, Inc....for up to $500 million in non-dilutive capital, of which $75 million drawn down at close and additional tranches will become available upon achievement of certain pre-specified milestones that are aligned with MoonLake’s strategy and funding needs."

Financing • Launch • Ankylosing Spondylitis • Hidradenitis Suppurativa

Impact of sonelokimab, a novel IL-17A- and IL-17F-inhibiting Nanobody, on multidomain clinical outcomes in active psoriatic arthritis: results from the randomized, double-blind, placebo-controlled Phase 2 ARGO trial (EULAR 2025) - No abstract available

Clinical • Clinical data • P2 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Effects of sonelokimab, an IL-17A- and IL-17F-inhibiting Nanobody, on patient-reported psoriatic arthritis symptoms and quality of life: results from the randomized, double-blind, placebo-controlled Phase 2 ARGO trial (EULAR 2025) - No abstract available

Clinical • HEOR • P2 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

IHS4-100 responses and other IHS4 outcomes with the IL-17A- and IL-17F-inhibiting Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS): Week 24 results from the Phase 2 MIRA trial (AAD 2025) - "Furthermore, for 1 in 4 patients, inflammatory remission in the form of IHS4-100 was possible after 24 weeks of treatment with sonelokimab 120mg. Ongoing Phase 3 trials will examine IHS4 outcomes with sonelokimab 120mg in a larger cohort of patients with moderate-to-severe HS."

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

Resolution of deep dermal inflammatory lesions with the Nanobody sonelokimab in moderate-to-severe hidradenitis suppurativa (HS): preclinical results and outcomes from the Phase 2 MIRA trial (AAD 2025) - "DDILs responded similarly to sonelokimab 240mg (n=41). In conclusion, DDILs are associated with a profound inflammatory and QoL burden in HS but may respond to treatment with a Nanobody designed to inhibit inflammation deep in the dermis."

P2 data • Preclinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain • CCL20 • CXCL8 • IL17A

MoonLake Immunotherapeutics Reports Full Year 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "With our pivotal HS data expected as of mid-2025, our focus is firmly on bringing this innovation to patients as we move towards commercialization...The Company will hold an in-person and virtual Capital Markets Update in the second quarter of 2025 to provide an update on the Phase 3 HS VELA program, discuss additional clinical data and update the market on financials."

P3 data • Hidradenitis Suppurativa

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Interleukin-17: A pleiotropic cytokine implicated in inflammatory, infectious, and malignant disorders. (PubMed, Cytokine Growth Factor Rev) - "Four FDA-approved drugs-secukinumab (for ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), ixekizumab (for ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), brodalumab (for plaque psoriasis), and bimekizumab (for plaque psoriasis)-suppress the IL-17 pathway, with more in development, including netakimab, sonelokimab, izokibep, and CJM112. These agents and others are being studied across a spectrum of disorders. Understanding the complicated interplay between IL-17 and other immune mediators may yield new treatments for inflammatory/autoimmune conditions and malignancies."

Journal • Ankylosing Spondylitis • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Skin Cancer • Solid Tumor • Spondylarthritis • IL17A • IL17C • IL17RA • IL23A

Antibodies to watch in 2025. (PubMed, MAbs) - "In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key..."

Journal • Review • Oncology

An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents with Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN) (clinicaltrials.gov) - P3 | N=35 | Recruiting | Sponsor: MoonLake Immunotherapeutics AG

New P3 trial • Dermatology • Hidradenitis Suppurativa • Immunology

MoonLake initiates three new clinical trials and further expands the portfolio of indications for the Nanobody sonelokimab (GlobeNewswire) - "New trials in three new indications have been initiated with the Nanobody sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)...Phase 2 and Phase 3 data read-outs across all target indications expected in 2025 (adult HS, and PPP) and 2026 (adolescent HS, PsA and axSpA)...Data from the VELA-TEEN trial may be combined with data from the Phase 3 VELA program in adults with moderate-to-severe HS to support a single Biologics License Application (BLA). Topline data for the primary and secondary endpoints, including the higher clinical response level of HiSCR75, are anticipated in 2026."

New P2 trial • New P3 trial • P2 data • P3 data: top line • Ankylosing Spondylitis • Dermatology • Hidradenitis Suppurativa • Inflammation

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-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

Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa. (PubMed, BioDrugs) - "Recently, secukinumab received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), while bimekizumab received approval from the EMA, for the treatment of moderate-to-severe HS in adults, with ongoing clinical trials aiming to further clarify the efficacy and safety of other drugs within this class...On the other hand, innovative drugs such as sonelokimab and izokibep show promising results and are currently in phase III clinical trials. This review provides a comprehensive overview of current knowledge and scientific advances in HS, focusing on the IL-17 pathway's role and its inhibition as a treatment strategy, alongside examining the most recent and significant clinical studies on various IL-17 inhibitors in the treatment of HS."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Efficacy and Safety of Sonelokimab, a Novel IL-17A- and IL-17F-Inhibiting Nanobody, in Patients with Active PsA: 24-Week Results from a Global, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial (ACR Convergence 2024) - P2 | "Patients were randomized 1:1:1:1:1 to sonelokimab 120 mg, sonelokimab 60 mg, sonelokimab 60 mg with no induction (NI), placebo, or adalimumab 40 mg Q2W (reference arm, not powered for statistical comparison). 24-week data from the ARGO Phase 2 trial in patients with active PsA demonstrate that the high levels of multidomain clinical responses achieved at W12 with the Nanobody sonelokimab are further improved upon continued treatment. There were no unexpected safety findings. These robust data support advancement of sonelokimab to Phase 3 trials."

Clinical • P2 data • Candidiasis • Dermatology • Dermatopathology • Immunology • Inflammation • Psoriasis • IL17A

MoonLake Immunotherapeutics starts Phase 3 IZAR program of the Nanobody sonelokimab in patients with active psoriatic arthritis (GlobeNewswire) - "MoonLake Immunotherapeutics...announced that the first patients have been screened at U.S. trial sites in its global Phase 3 clinical program, IZAR, evaluating sonelokimab, an investigational Nanobody designed to treat inflammatory disease, in patients with active psoriatic arthritis (PsA)....Following the positive results from the Phase 2 ARGO trial, the Phase 3 IZAR program is expected to enroll approximately 1,500 adult patients across two trials, IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089)....The readout of the primary endpoint for both IZAR-1 and IZAR-2 is anticipated in H1 2026."

P1 data • Trial status • Psoriatic Arthritis

The Nanobody® Sonelokimab in Patients with Moderate-To-Severe HS: MIRA Phase 2 Week 24 IHS4 Results (SHSA 2024) - P2 | "Discussion Sonelokimab demonstrated substantial improvements in IHS4 to W24. The ongoing Phase 3 VELA 1 and 2 trials will further examine IHS4 outcomes with sonelokimab 120mg in patients with moderate-to-severe HS."

Clinical • P2 data • IL17A

Network Meta-Analysis of Efficacy and Safety of Medical Interventions for Hidradenitis Suppurativa (SHSA 2024) - "Compared with placebo, the following treatments had significantly higher HiSCR-50 response rates: sonelokimab 120mg Q4W, lutikizumab 300mg Q2W, adalimumab 40mg QW, sonelokimab 240mg Q2W, bimekizumab 320mg Q2W, povorcitinib 15mg QD, bimekizumab 320mg Q4W, secukinumab 300mg Q4W, and secukinumab 300mg Q2W. Specific numerical results and figures will be presented if accepted. Discussion In the absence of head-to-head active-comparator trials, this analysis may help inform treatment decisions for clinicians and patients with HS."

Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology

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

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

Evidence of a role for IL-17F in the inflammatory mechanisms underlying hidradenitis suppurativa (HS), including in deep dermal tunnels (EADV 2024) - "Nodules and tunnels exhibited greater pro-inflammatory chemokine and cytokine expression, immune cell infiltration, and keratinocyte proliferation compared with perilesional skin, with highest levels in tunnel tissue, indicating that tunnels represent the major source of inflammation in HS. IL-17F has a significant pro-inflammatory role, together with IL-17A, in the HS disease cascade. Sonelokimab demonstrated greater inhibition of CCL20 and CXCL8 expression compared with secukinumab or bimekizumab in IL-17-stimulated NHEKs and compared with adalimumab or bimekizumab in an ex vivo HS tunnel model."

Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain • CCL20 • CXCL8 • IL17A • ITGAX

Efficacy and safety of sonelokimab, a novel IL-17A- and IL-17F-inhibiting Nanobody, in patients with active psoriatic arthritis (PsA): Week 12 skin, nail, and multidomain outcomes from the global, randomized, double-blind, placebo-controlled Phase 2 ARGO trial (EADV 2024) - P2 | "Patients were randomized (1:1:1:1:1; stratified by sex and prior biologic use) to sonelokimab 60mg Q4W no induction (NI) , sonelokimab 60mg Q4W (with induction) , sonelokimab 120mg Q4W (with induction) , placebo, or adalimumab 40mg Q2W (reference arm, not powered for statistical comparison); induction dosing for sonelokimab was Q2W until W8 (except in the NI arm) . In the ARGO Phase 2 trial in patients with active PsA, sonelokimab 60mg and 120mg (with induction) achieved high levels of response in skin, nail, and multidomain endpoints by W12, demonstrating the potential of both doses to improve outcomes across PsA domains. These findings warrant further investigation in Phase 3 trials."

Clinical • P2 data • Candidiasis • Dermatology • Dermatopathology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

The IL-17A- and IL-17F-inhibiting nanobody sonelokimab in patients with moderate‑to‑severe hidradenitis suppurativa (HS): Week 24 International Hidradenitis Suppurativa Severity Score System (IHS4) results from the Phase 2 MIRA trial (EADV 2024) - P2 | "In the MIRA trial, the IL-17A- and IL-17F-inhibiting Nanobody sonelokimab demonstrated substantial improvements in IHS4 to W24, owing to efficacy across all three key inflammatory HS lesion types. These findings are consistent with previously reported high HiSCR 75 responses. The ongoing Phase 3 VELA 1 and 2 trials will further examine IHS4 outcomes with sonelokimab 120mg in patients with moderate-to-severe HS."

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