AnaptysBio's investigational drug ANB032, a B and T lymphocyte attenuator (BTLA) agonist, has failed to meet its primary and secondary endpoints in the Phase 2b ARISE-AD trial for the treatment of moderate-to-severe atopic dermatitis (AD), also known as eczema. The global, 201-patient trial assessed ANB032 as a monotherapy. The company announced the disappointing results, stating that further investment in ANB032 would be discontinued.
The ARISE-AD study enrolled patients in the U.S., Canada, Europe, Australia, and New Zealand, with a mean baseline Eczema Area and Severity Index (EASI) score of 27.3. Participants were either biologic-naive (n=168) or had prior experience with dupilumab or other IL-13 therapies (n=33). Patients were randomized to receive subcutaneous ANB032 at doses of 100mg every four weeks, 400mg every four weeks, 400mg every two weeks, or placebo for a 12-week period. The primary endpoint was the proportion of patients achieving at least a 75% improvement from baseline in EASI score (EASI-75) at Week 14.
Efficacy and Safety Results
The results indicated that ANB032 did not meet the primary endpoint of EASI-75, nor did it achieve any of the secondary endpoints, including EASI-90, mean change in baseline EASI, or a 4-point reduction in itch severity as measured by the peak Pruritus Numerical Rating Scale (PNRS) versus placebo. Notably, placebo response rates, particularly in the U.S., were higher than historical norms.
Despite the lack of efficacy, ANB032 demonstrated a favorable safety profile, with no significant safety signals observed across all doses. The most common adverse events (>5%) were nasopharyngitis, atopic dermatitis, and headache. One participant in each of the active dose arms experienced a serious adverse event (SAE) of worsening AD, while two placebo participants experienced SAEs.
Company's Future Direction
Daniel Faga, president and chief executive officer of Anaptys, expressed disappointment in the results but affirmed the company's commitment to its broader immunology portfolio. "While ANB032 was safe and well tolerated, we’re disappointed by these efficacy results in AD and will discontinue further investment in this asset. Moving forward, our resources and capital will be focused on the rest of our exciting autoimmune portfolio," said Faga.
AnaptysBio is shifting its focus to other assets, including rosnilimab, a depleter and agonist targeting PD-1+ T cells, which is currently in Phase 2b development for rheumatoid arthritis with top-line data expected in February 2025, and in Phase 2 development for ulcerative colitis with top-line data expected in Q1 2026. The company also plans to advance ANB033, an anti-CD122 antagonist, and ANB101, a BDCA2 modulator, with Phase 1b data anticipated from both programs.
With approximately $415 million in cash at year-end 2024, AnaptysBio anticipates its cash runway will extend through year-end 2027, excluding potential milestones and royalties from its collaboration with GSK.
