Drugs / M1095
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02156466 | Aug 2014 → Aug 2015 | psoriasis | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 23 trials · 3 met primary | ||||||
| Phase 2 | NCT05640245 | Dec 2022 → Sep 2023 | psoriatic arthritis | MoonLake Immunotherapeutics AG | Completed | Met primary |
| Phase 2 | NCT05322473 | Apr 2022 → May 2023 | hidradenitis suppurativa | MoonLake Immunotherapeutics AG | Completed | Met primary |
| Phase 2 | NCT03384745 | Jul 2018 → Jun 2019 | psoriasis | Bond Avillion 2 Development LP | Completed | Met primary |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT07223138 | Nov 2025 → Feb 2028 expected | psoriatic arthritis | MoonLake Immunotherapeutics AG | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT07007637 | Jun 2025 → Jun 2028 expected | hidradenitis suppurativa | MoonLake Immunotherapeutics AG | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06768671 | Dec 2024 → Sep 2026 overdue | hidradenitis suppurativa | MoonLake Immunotherapeutics AG | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06641076 | Oct 2024 → May 2026 overdue | psoriatic arthritis | MoonLake Immunotherapeutics AG | Active not recruiting | Met primary |
| Phase 3 | NCT06641089 | Oct 2024 → Jan 2027 expected | psoriatic arthritis | MoonLake Immunotherapeutics AG | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06411899 | May 2024 → Sep 2025 | hidradenitis suppurativa | MoonLake Immunotherapeutics AG | Completed | No outcome recorded |
| Phase 3 | NCT06411379 | May 2024 → Aug 2025 | hidradenitis suppurativa | MoonLake Immunotherapeutics AG | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-08-10 | MoonLake Immunotherapeutics AG | Results MoonLake Announces Positive Topline Results from the Phase 3 IZAR-1 Trial of Sonelokimab in Psoriatic Arthritis Demonstrating Significant Improvements Across all Clinical Endpoints, and Reports Second Quarter 2026 Financial Results moonlaketx.com ↗
In patients with concomitant skin involvement, 61% achieved PASI90 at Week 16. |
| 2026-06-21 | MoonLake Immunotherapeutics AG | Results MoonLake Announces Week 52 Results of Sonelokimab from its Phase 3 VELA Program in Hidradenitis Suppurativa and Confirms Investor Day on June 22, 2026 moonlaketx.com ↗
Namely, ~67% of patients treated with SLK achieved HiSCR75 at the one-year mark, with more than one quarter of patients achieving inflammatory remission (IHS4-100), and around one third reaching HiSCR100 |
| 2026-03-28 | MoonLake Immunotherapeutics AG | Results MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting moonlaketx.com ↗
Patients treated with SLK also showed substantial improvements in HiSQOL items at week 40 versus baseline, ranging from 41% (pain), to 54% (walking, getting dressed) to 62% (down or depressed) |
| 2026-02-22 | MoonLake Immunotherapeutics AG | Results MoonLake Announces Positive Topline Results from its Phase 2 Clinical Trial of Sonelokimab in Axial Spondyloarthritis and Reports 2025 Financial Results moonlaketx.com ↗
In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12 |
| 2026-02-02 | MoonLake Immunotherapeutics AG | Regulatory MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day moonlaketx.com ↗ |
| 2026-01-08 | MoonLake Immunotherapeutics AG | Regulatory MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day moonlaketx.com ↗
FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA trials |
| 2025-11-05 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab moonlaketx.com ↗
Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefit |
| 2025-09-28 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab moonlaketx.com ↗
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<0.001) |
| 2024-06-10 | MoonLake Immunotherapeutics AG | Regulatory MoonLake Immunotherapeutics Announces Positive Regulatory Feedback from both FDA and EMA on Path for the Phase 3 Program for the Nanobody® sonelokimab in Psoriatic Arthritis moonlaketx.com ↗
Clarified path for PsA Phase 3 program with study design, patient population and endpoints agreed |
| 2024-03-10 | MoonLake Immunotherapeutics AG | Results MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day moonlaketx.com ↗
The ARGO trial, which involved 207 patients with active PsA, demonstrated that the primary endpoint, the American College of Rheumatology (ACR) 50, continued to improve from week 12 and exceeded 60% by week 24. |
| 2024-02-26 | MoonLake Immunotherapeutics AG | Regulatory MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS) moonlaketx.com ↗ |
| 2023-11-05 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics announces landmark Phase 2 results for Nanobody® sonelokimab in active psoriatic arthritis moonlaketx.com ↗
MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced positive top-line results from its global Phase 2 ARGO trial evaluating the efficacy and safety of the Nanobody ® sonelokimab in patients with active psoriatic arthritis (PsA). |
| 2023-10-15 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa moonlaketx.com ↗
Maintenance treatment with sonelokimab dosed every 4 weeks (Q4W), demonstrated that 57% of patients achieved HiSCR75 at week 24, increasing the landmark week 12 responses (primary endpoint) by over 10 ppt (percentage points) |
| 2023-10-11 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics presents positive 12-week data from the Phase 2 MIRA trial with Nanobody® Sonelokimab for Hidradenitis Suppurativa at the European Academy of Dermatology and Venereology Congress moonlaketx.com ↗
HiSCR75 primary endpoint met with a significantly higher proportion of patients on sonelokimab 120mg (43.3%) compared to placebo (14.7%) achieving HiSCR75 at week 12; a 29 percentage points (ppt) delta (p<0.001) |
| 2023-08-10 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics Reports Second Quarter 2023 Financial Results and Provides a Business Update moonlaketx.com ↗
Achieved landmark milestone with positive results from Phase 2 MIRA trial in hidradenitis suppurativa (HS) |
| 2023-06-25 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics achieves landmark milestone with positive Phase 2 results for Nanobody® sonelokimab in hidradenitis suppurativa moonlaketx.com ↗
Primary endpoint HiSCR75 met with 29 percentage points (ppt) delta vs placebo (p=0.0002) at week 12, setting a new bar in HS |
| 2022-09-26 | MoonLake Immunotherapeutics AG | Regulatory MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody® sonelokimab in patients with active psoriatic arthritis moonlaketx.com ↗ |
| 2022-05-09 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics announces the publication of new long-term disease control data from a Phase 2b Psoriasis trial of the Nanobody® sonelokimab moonlaketx.com ↗
The dataset shows that with the optimal dose of sonelokimab (120mg Q4W) more patients achieved complete skin clearance at week 24 than in patients treated with the IL-17A inhibiting antibody secukinumab (56.9% vs. 34.0% respectively, exploratory P = 0.019). |
| 2021-05-06 | MoonLake Immunotherapeutics AG | Results MoonLake Immunotherapeutics announces publication in The Lancet moonlaketx.com ↗
Sonelokimab showed impressive efficacy with a favorable safety profile, and numerically outperformed active control secukinumab. |
| 2020-09-11 | EMD Serono Research & Development Institute, Inc. | Results Merck KGaA, Darmstadt, Germany Announces Positive Phase II Results for Investigational Sonelokinab (M1095) in Patients with Moderate to Severe Chronic Plaque-Type Psoriasis emdserono.com ↗
Merck KGaA, Darmstadt, Germany today announced positive top-line results from a Phase II study of sonelokinab (M1095), an investigational anti-IL-17 A/F Nanobody®, which neutralizes both IL-17A and IL-17F. |
All press releases naming this drug 31 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | M1095 | “Drug: Sonelokimab (M1095)” NCT05322473 ↗ |
| Known as | ALX-0761 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298023 ↗ |
| Known as | MSB0010841 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02156466 ↗ |
| Known as | SLK | “trial of sonelokimab (SLK), a nanobody that binds with a similarly high affinity to IL-17A and IL-17F, inhibiting all dimers.” PMID 41053449 ↗ Oct 2025 |
| Known as | Sonelokimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05640245 ↗ |
| Action | Inhibit | “Interleukin 17A inhibitor” CHEMBL4298023 ↗ |
| Modality | Protein / enzyme biologic | “MSB0010841(Anti- IL-17A/F Nanobody)” NCT02156466 ↗ |
| Route | Subcutaneous | “as SC injection” NCT02156466 ↗ |
| Target | IL17A | “Interleukin 17A inhibitor” CHEMBL4298023 ↗ |
| Target | IL17F | “Interleukin-17F inhibitor” CHEMBL4298023 ↗ |