- Enrollment ongoing for global Phase 2b trial to treat atopic dermatitis (AD) with ANB032, our BTLA agonist, with top-line data anticipated by year-end 2024
- Enrollment ongoing for global Phase 2b trial to treat rheumatoid arthritis (RA) and global Phase 2 trial to treat ulcerative colitis (UC) with rosnilimab, our PD-1 agonist, with top-line data anticipated by mid 2025 and H1 2026, respectively
- IND filings for ANB033 (anti-CD122 antagonist) and ANB101 (BDCA2 modulator) anticipated Q2 2024 and H2 2024, respectively
- Year end 2023 cash and investments of $417 million and reiterating cash runway through year-end 2026
SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported operating results for the fourth quarter and year ended December 31, 2023 and provided a business update.
“2023 was a remarkable year for Anaptys as we implemented a multi-year development plan investing across our best-in-class immune cell modulators (ICMs) to bring transformational medicines to patients living with heterogeneous, systemic autoimmune and inflammatory diseases, with the goal of restoring immune balance,” said Daniel Faga, president and chief executive officer of Anaptys. “Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis. Additionally, we expanded our portfolio by acquiring the rights to ANB101, a BDCA2 modulator, which targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation.”
“We will have a number of important events in 2024 including the top-line data readout of ANB032's Phase 2b trial in atopic dermatitis by year end,” adds Faga. “We also plan to move our third and fourth ICMs -- ANB033, our anti-CD122 antagonist, and ANB101 -- into the clinic this year, with IND filings planned for Q2 and H2, respectively.”
Updates on Wholly Owned Immune Cell Modulator Pipeline
ANB032 (BTLA agonist antibody)
- Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (AD)
- 160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1
- Reiterating top-line Week 14 data anticipated by year-end 2024
- Presented poster on ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function, representing one of the mechanisms to address atopic dermatitis pathophysiology, at the 2024 AAD Annual Meeting in March 2024
- Poster presentation is available here
Rosnilimab (PD-1 agonist antibody)
- Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA
- 420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
- At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI
- 420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70