Anaptys' Phase 2b Trial of ANB032 Fails to Meet Endpoints in Atopic Dermatitis

SAN DIEGO, CA, USA I December 11, 2024 I AnaptysBio, Inc. (Nasdaq: ANAB), a company dedicated to advancing breakthroughs in immunology therapeutics, has reported that its investigational drug, ANB032, did not achieve the desired outcomes in a clinical trial. The trial, known as ARISE-AD, was conducted with 201 patients to assess the efficacy of ANB032 as a monotherapy for moderate-to-severe atopic dermatitis (AD), commonly known as eczema. Despite the drug being well tolerated with no safety concerns, it failed to meet both primary and secondary endpoints.

Daniel Faga, the president and CEO of AnaptysBio, expressed disappointment at the results, stating that further investment in ANB032 would be halted. Instead, the company plans to redirect its efforts and capital towards its remaining autoimmune projects. AnaptysBio is particularly focused on its lead program, rosnilimab, which targets PD-1+ T cells. The company is gearing up to release Phase 2b data for rheumatoid arthritis in February 2025, followed by data for ulcerative colitis in the first quarter of 2026. Additionally, AnaptysBio anticipates sharing Phase 1b data from two other ongoing programs.

The ARISE-AD trial was an evaluation of ANB032’s efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients diagnosed with moderate-to-severe AD. Participants had a mean baseline EASI score of 27.3 and were enrolled from multiple regions, including the U.S., Canada, Europe, Australia, and New Zealand. Patients were either new to biologics or had prior experience with treatments such as dupilumab or other IL-13 therapies. They were randomly assigned to receive ANB032 in one of three dosing regimens or a placebo for a period of 12 weeks.

The trial’s primary endpoint was the percentage of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index score (EASI-75) by Week 14. Secondary endpoints included achieving EASI-90, changes in baseline EASI scores, and a reduction in itch severity as measured by the Pruritus Numerical Rating Scale (PNRS). Unfortunately, ANB032 did not meet any of these endpoints when compared to the placebo.

While ANB032 showed some potential with durable responses in certain measures, the placebo group displayed unexpectedly high response rates, particularly in the U.S. Despite this outcome, ANB032 demonstrated a strong safety profile, with adverse events (AEs) similar to previous studies. The most common AEs included nasopharyngitis, atopic dermatitis, and headaches, none of which showed any dose relationship or imbalance.

Dr. Paul Lizzul, AnaptysBio’s chief medical officer, expressed gratitude to the participants and medical professionals involved in the trial, acknowledging their contributions to advancing the understanding of treating chronic diseases like eczema.

AnaptysBio continues to focus on developing immunology therapeutics aimed at autoimmune and inflammatory diseases. The company’s portfolio includes rosnilimab and other promising antibodies in clinical development phases. AnaptysBio also has a partnership with GSK for several therapeutic antibodies in the field of immuno-oncology.