ARCA biopharma's rNAPc2 fails to meet primary endpoint in Phase 2b COVID-19 trial

Oruka Therapeutics, Inc.

Pooled rNAPc2 reduced D-dimer 16.8% vs heparin 11.2% (P=0.47), missing statistical significance.
Per-protocol analysis: rNAPc2 reduced D-dimer 28.7% vs heparin increase 1.1% (P=0.33).
In WHO Severe patients, heparin D-dimer increased 29.0% (P=0.022); rNAPc2 changed 25.9% (P=0.16).
Thrombotic events: 9 in heparin group vs 6 in rNAPc2; hazard ratio for recovery 0.88, neither significant.
Company will not pursue direct superiority trial vs heparin for COVID-19; evaluating partnering and strategic options.

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