Biopharma asset separation
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Anaptys Announces Phase 2 Trial of Rosnilimab Did Not Meet Primary or Secondary Endpoints at Week 12 in Moderate-to-Severe Ulcerative Colitis
Globenewswireยท 2025-11-10 14:00
Core Insights - AnaptysBio announced that rosnilimab was safe and well tolerated but failed to meet primary and key secondary endpoints in a Phase 2 trial for moderate-to-severe ulcerative colitis, leading to the discontinuation of the trial and an estimated savings of at least $10 million [1][6][9] Group 1: Trial Results - The Phase 2 trial enrolled 136 patients with a baseline mean modified Mayo Score (mMS) of 6.7, who had inadequate responses to prior therapies [2][3] - At Week 12, clinical remission was achieved by 7% of patients receiving rosnilimab, compared to 5% and 4% for endoscopic remission [3][4] - Blood biomarker data indicated ~90% depletion of pathogenic T cells at Week 12, consistent with previous studies [4][6] Group 2: Future Plans - The company remains optimistic about advancing rosnilimab in rheumatoid arthritis (RA) and plans to provide updates in H1 2026, with funding expected from strategic sources without diluting royalties [2][6] - AnaptysBio intends to separate its biopharma assets from its royalty assets by 2026, which includes Jemperli royalties projected to exceed $390 million annually [2][11] Group 3: Safety Profile - Rosnilimab demonstrated a favorable safety profile, with adverse events primarily mild to moderate, including nasopharyngitis and dizziness [7][13] - No serious adverse events or malignancies were reported, and the ongoing safety profile remains consistent with previous studies [8][13]