---
schema_version: "secwatch.filing_event.v1"
accession: "0001013762-23-003933"
form_type: "8-K"
ticker: "MLTX"
cik: "0001821586"
company_name: "MoonLake Immunotherapeutics"
filed_at: "2023-10-16T23:59:59+00:00"
generated_at: "2026-06-09T23:29:14.748906+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# MoonLake announces positive 24-week Phase 2 MIRA results; 57% HiSCR75, 120mg dose confirmed for Phase 3

## Summary
- 57% of patients on sonelokimab 120mg achieved HiSCR75 at week 24 (+10 ppt from week 12); 38% achieved HiSCR90 (+14 ppt).
- Complete inflammatory remission (IHS4-100) in 24% of patients; 31% AN 100 and 49% DT 100 at week 24 with 120mg.
- 120mg Q4W maintenance dose confirmed as optimal based on efficacy, safety, and pharmacokinetics; safety consistent with IL-17 class.
- Adalimumab non-responders switching to sonelokimab at week 12 achieved HiSCR75 rates similar to patients randomized to sonelokimab at baseline.
- Company on track to discuss Phase 3 development plans with FDA by end of 2023.

## SEC filing metadata
- accession: 0001013762-23-003933
- form_type: 8-K
- ticker: MLTX
- cik: 0001821586
- company_name: MoonLake Immunotherapeutics
- filed_at: 2023-10-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1821586/000101376223003933/0001013762-23-003933-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1821586/000101376223003933/ea186779-8k_moonlake.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001013762-23-003933
- JSON: https://secwatch.observer/filing/0001013762-23-003933.json
- Plain text: https://secwatch.observer/filing/0001013762-23-003933.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.