secwatch.observer — SEC 8-K summary
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Issuer:     Protagonist Therapeutics, Inc (PTGX)
CIK:        0001377121
Form:       8-K
Filed at:   2025-03-10T23:59:59+00:00
Accession:  0001104659-25-021986
Event type: other_material
Sentiment:  positive
Materiality: 1.00
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Icotrokinra Phase 3 PsO hits 46% complete skin clearance; UC Phase 2b meets endpoint
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- Phase 3 ICONIC-LEAD: 46% of icotrokinra patients achieved IGA 0 (completely clear skin) at Week 24; 74% IGA 0/1.
- ICONIC-ADVANCE 1&2 met co-primary endpoints and showed superiority over deucravacitinib at Weeks 16 and 24; head-to-head vs ustekinumab (ICONIC-ASCEND) initiated.
- Phase 2b ANTHEM-UC: 63.5% clinical response at highest dose at Week 12 vs 27.0% placebo (p<0.001); 30.2% clinical remission vs 11.1% (p<0.001).
- Both studies show favorable safety; AEs similar to placebo. Icotrokinra is a first-in-class oral IL-23 receptor antagonist.
- Results support potential paradigm shift in plaque psoriasis and ulcerative colitis; partner J&J advancing program.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1377121/000110465925021986/0001104659-25-021986-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1377121/000110465925021986/tm258665d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-021986

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer