---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-24-031426"
form_type: "8-K"
ticker: "AVTX"
cik: "0001534120"
company_name: "Avalo Therapeutics, Inc."
filed_at: "2024-07-09T23:59:59+00:00"
generated_at: "2026-05-31T22:34:55.617561+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Avalo Therapeutics IND for AVTX-009 active; Phase 2 LOTUS trial in hidradenitis suppurativa to commence

## Summary
- FDA cleared IND for AVTX-009 (anti-IL-1β mAb) allowing Phase 2 LOTUS trial in moderate-to-severe HS.
- LOTUS is a randomized, placebo-controlled trial of ~180 adults with two AVTX-009 dose regimens; primary endpoint HiSCR75 at Week 16.
- First patient enrollment expected in 2024; AVTX-009 acquired in late March 2024 with IND filed ~3 months later.
- Company believes AVTX-009 may be best-in-class due to target, half-life, and potency allowing convenient dosing.

## SEC filing metadata
- accession: 0001628280-24-031426
- form_type: 8-K
- ticker: AVTX
- cik: 0001534120
- company_name: Avalo Therapeutics, Inc.
- filed_at: 2024-07-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1534120/000162828024031426/0001628280-24-031426-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1534120/000162828024031426/avtx-20240709.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-24-031426
- JSON: https://secwatch.observer/filing/0001628280-24-031426.json
- Plain text: https://secwatch.observer/filing/0001628280-24-031426.txt

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