AnaptysBio’s Rosnilimab Shows Promising Results in Phase 2b Rheumatoid Arthritis Trial
AnaptysBio's PD-1 agonist rosnilimab achieved positive results in a Phase 2b trial for rheumatoid arthritis (RA)13.
The trial met its primary endpoint, demonstrating statistically significant changes from baseline in disease activity after 12 weeks across all tested doses1.
Rosnilimab showed the highest ever reported Clinical Disease Activity Index (CDAI) low disease activity response at three months, with 69% of patients achieving low disease activity by week 1437.
The drug works by depleting PD-1 high T cells and agonizing remaining PD-1+ T cells, potentially restoring immune system balance48.
Rosnilimab demonstrated a favorable safety and tolerability profile, with adverse event rates similar to placebo7.
The treatment showed robust pharmacological activity, including a reduction in PD-1 high T cells, an increase in total Tregs, and a reduction in C-reactive protein (CRP) across all doses7.
AnaptysBio's approach with rosnilimab represents a potentially new paradigm in RA treatment, aiming to reset the immune system rather than just suppress symptoms8.
The company anticipates announcing full 28-week data and additional translational RA data in Q2 20257.
Sources:
1. https://www.fiercebiotech.com/biotech/anaptysbios-pd-1-drug-reduces-rheumatoid-arthritis-phase-2-trial
3. https://www.clinicaltrialsarena.com/news/anaptysbio-achieves-highest-ever-results-in-phase-ii-rheumatoid-arthritis-trial/
4. https://endpts.com/anaptysbio-gets-a-mid-stage-win-for-pd-1-drug-in-rheumatoid-arthritis/
7. https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-rosnilimab-achieved-positive-results-ra-phase
8. https://www.drugdiscoverytrends.com/pd-1-agonists-show-promise-in-treating-rheumatoid-arthritis-by-restoring-immune-balance/