secwatch.observer — SEC 8-K summary
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Issuer:     Protagonist Therapeutics, Inc (PTGX)
CIK:        0001377121
Form:       8-K
Filed at:   2022-04-26T23:59:59+00:00
Accession:  0001104659-22-049856
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PN-943 Phase 2 IDEAL study shows 27.5% clinical remission at 150mg BID; 13% delta vs placebo
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- PN-943 150mg BID achieved 27.5% clinical remission vs 14.5% placebo (delta 13%, p=0.08); bio-naïve delta 16% (p=0.04).
- Statistically significant histological remission (RHI≤6) at 37.2% vs 14.3% placebo (delta 23%, p=0.0107).
- Endoscopic improvement: 43.1% vs 16.4% placebo (delta 26.7%, p=0.0023).
- 450mg BID showed no efficacy, consistent with bell-shaped dose-response observed for other α4β7 integrin antagonists.
- No drug-related SAEs; safety profile similar to placebo; company plans to advance to Phase 3 registrational study.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1377121/000110465922049856/0001104659-22-049856-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1377121/000110465922049856/tm2213399d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-049856

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