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Investing.com -- Shares of AnaptysBio, Inc. (NASDAQ:ANAB) surged over 60% following the announcement of positive results from a Phase 2b trial of rosnilimab, its investigational treatment for rheumatoid arthritis (RA). The company’s press release on February 12, 2025, detailed that rosnilimab achieved statistical significance in its primary endpoint at Week 12 and demonstrated the highest ever reported Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) responses over a six-month period.
The global 424-patient Phase 2b RENOIR trial evaluated the efficacy and safety of rosnilimab in patients with moderate-to-severe RA. The trial met its primary endpoint, showing a mean change from baseline in DAS-28 CRP at Week 12 across all doses compared to placebo. It also achieved statistical significance on key secondary endpoints, including ACR20, ACR50, and CDAI LDA at Week 12, with sustained and potentially deepening responses observed at Week 28.
Rosnilimab was reported to be safe and well-tolerated, with adverse event rates similar to placebo. The treatment demonstrated robust pharmacological activity, with a reduction in PD-1high T cells and an increase in total T regulatory cells, contributing to healthy immune homeostasis.
Daniel Faga, president and chief executive officer of AnaptysBio, expressed optimism about the trial results and the potential impact on the RA market, which is valued at approximately $20 billion in the U.S. The company anticipates reporting complete Week 28 data and additional translational data in the second quarter of 2025, as well as top-line Week 12 Phase 2 data for rosnilimab in ulcerative colitis in the fourth quarter of 2025.
The positive trial results have not only demonstrated rosnilimab’s potential in treating RA but have also validated AnaptysBio’s scientific approach in targeting PD-1 co-inhibitory receptors on activated immune cells for systemic autoimmune and inflammatory diseases.
As of the December 10, 2024 data cutoff, the safety profile for patients who achieved CDAI LDA through Week 14 and continued active therapy up to Week 28 remains consistent with the reported profile through Week 12. Further trial details can be found on ClinicalTrials.gov.
The surge in AnaptysBio’s stock price reflects investor confidence in the potential of rosnilimab to become a significant player in the RA treatment landscape. However, it is important to note that rosnilimab is still under clinical investigation, and its safety and efficacy have not yet been evaluated by any regulatory authority.
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