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AnaptysBio Inc. (NASDAQ:ANAB) on Monday released data from the Phase 2 trial of rosnilimab for moderate-to-severe ulcerative colitis.
Investigational rosnilimab was safe and well-tolerated; however, it did not meet the primary endpoint of the mean change from baseline in the modified Mayo Score (severity of ulcerative colitis, mMS) or the key secondary endpoints of clinical response and clinical remission at Week 12.
Placebo rates in the trial were within expected historical ranges.
The company will discontinue the ulcerative colitis trial, resulting in at least $10 million in savings.
Also Read: AnaptysBio’s Arthritis Drug Matches Top Therapies In Phase 2 Trial, Analyst Sees Turning Point
“…We remain excited about the potential advancement of rosnilimab in RA and will provide an update in H1 2026, including funding by strategic or other sources of capital without diluting our royalties,” said Daniel Faga, president and CEO of Anaptys.
The company on Monday said, regardless of prior treatment, rosnilimab performed no better than placebo at Week 12, with clinical remission achieved by 7% of patients receiving rosnilimab 400mg Q4W or 800 mg Q2W, and 5% and 4% of patients achieving endoscopic remission, respectively.
While preliminary data suggest an increase in remission rates between Week 12 and Week 24, Week 24 remission rates did not meet the six-month target product profile.
Consistent with prior rosnilimab studies, a favorable safety and tolerability profile was observed, even at a 33% higher cumulative dose through 6 months in the 800mg Q2W cohort relative to the highest dose studied, 600mg Q2W, in the RA Phase 2b trial.
The ongoing safety profile, including for patients through end-of-treatment at Week 50, remains consistent with the reported profile of all rosnilimab-treated patients through Week 12, as well as what was observed in the RA study. There have been no reported cases of malignancy or additional MACE.
The company is conducting a Phase 1b study for ANB033 for celiac disease, and plans to announce a Phase 1b in another inflammatory disease in 2026.
Simultaneously, Anaptys reiterated its intention to separate biopharma assets from substantial royalty assets in 2026, including Jemperli royalties of >$390 million per year at GSK plc’s (NYSE:GSK) peak sales guidance of >$2.7 billion, which Anaptys expects to be achieved before 2031.
ANAB Price Action: AnaptysBio shares were down 13.63% at $34.24 at the time of publication on Monday, according to Benzinga Pro data.
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