AnaptysBio Announces Upcoming Phase 2b Data for ANB032 in Atopic Dermatitis and Rosnilimab in Rheumatoid Arthritis
核心洞察
AnaptysBio (搜索) anticipates top-line Phase 2b data for ANB032, a BTLA (搜索) agonist, in atopic dermatitis (搜索) in December 2024, assessing its efficacy and safety over 14 weeks.
Rosnilimab, a PD-1 (搜索) agonist, is expected to have top-line Phase 2b data in rheumatoid arthritis (搜索) in February 2025, following a 12-week placebo-controlled trial.
A Phase 1 trial has been initiated for ANB033, an anti-CD122 (搜索) antagonist, in healthy volunteers, with the Phase 1b indication to be disclosed in 2025.
AnaptysBio (搜索), Inc. (Nasdaq: ANAB) has announced key milestones for its clinical-stage immunology therapeutics, with top-line data readouts expected for ANB032 in atopic dermatitis (搜索) (AD) and rosnilimab in rheumatoid arthritis (搜索) (RA). The company also reported its third-quarter 2024 financial results and provided a business update, highlighting a strong cash position to support ongoing research and development.
ANB032 Phase 2b Trial in Atopic Dermatitis
Top-line data from the global Phase 2b trial of ANB032, a BTLA (搜索) agonist antibody, in moderate-to-severe AD is anticipated in December 2024. The trial enrolled approximately 200 patients, randomized 1:1:1:1 across three dose levels of subcutaneously administered ANB032 and a placebo arm. The 14-week treatment duration is followed by a six-month off-drug follow-up period, with efficacy assessed using well-established endpoints such as EASI-75 and IGA 0/1. Notably, around 15% of enrolled patients had prior experience with Dupixent/anti-IL-13 treatment.
AnaptysBio (搜索) presented analyses at the European Academy of Dermatology and Venerology (EADV) Congress in September 2024, characterizing a BTLA (搜索) transcriptomic signature in AD, providing further insight into the drug's mechanism of action.
Rosnilimab Phase 2b Trial in Rheumatoid Arthritis
Top-line data from the global Phase 2b trial of rosnilimab, a PD-1 (搜索) agonist antibody, in moderate-to-severe RA is anticipated in February 2025. The trial has completed enrollment of approximately 420 patients, randomized 1:1:1:1 across three dose levels of subcutaneously administered rosnilimab and a placebo arm. The 12-week treatment duration employs endpoints including DAS28-CRP, CDAI, and ACR20/50/70.
Patients treated with rosnilimab who achieve low disease activity (CDAI<=10) at Week 14 are eligible for an additional 16-week all-active treatment period, followed by a three-month off-drug follow-up period.
Enrollment is ongoing for a global Phase 2 trial in moderate-to-severe ulcerative colitis (搜索) (UC), involving 132 patients randomized 1:1:1 to two dose levels of rosnilimab or placebo. Top-line Week 12 data is anticipated in Q1 2026. An optional 26-week, blinded treatment extension period (TEP) was implemented in October 2024 for patients in the U.S. who remain in clinical response at Week 24.
ANB033 Phase 1 Trial
A Phase 1 trial has been initiated in healthy volunteers for ANB033, an anti-CD122 (搜索) antagonist antibody, in October 2024. The Phase 1b indication is expected to be disclosed in 2025.
Financial Status
AnaptysBio (搜索) reported cash and investments of $458.0 million as of September 30, 2024, reiterating its cash runway through year-end 2026. Third-quarter collaboration revenue was $30.0 million, compared to $3.3 million for the same period in 2023, driven by a $15.0 million commercial milestone for annual Jemperli sales exceeding $250.0 million and increased royalties. Research and development expenses were $42.2 million for the quarter, compared to $30.9 million in 2023, primarily due to development costs for rosnilimab, ANB032, ANB033, and ANB101.