- Enrollment ongoing for global Phase 2b trial to treat atopic dermatitis (AD) with ANB032, our BTLA agonist; reiterating 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; reiterating top-line data anticipated by mid 2025 and H1 2026, respectively
- IND submissions for ANB033 (anti-CD122 antagonist) and ANB101 (BDCA2 modulator) anticipated Q2 2024 and H2 2024, respectively
- Announced positive top-line GEMINI-2 Phase 3 trial results of imsidolimab, our IL-36R mAb, in generalized pustular psoriasis
- Announced a $50 million capped non-recourse royalty monetization from amended agreement with Sagard in exchange for additional Jemperli royalties
SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.
“This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist. By year end, we anticipate sharing top-line data from ANB032's Phase 2b trial in atopic dermatitis, as well as moving our two preclinical immune cell modulators, ANB033 and ANB101, into clinical development,” said Daniel Faga, president and chief executive officer of Anaptys. “Additionally, we are excited to further strengthen our balance sheet by adding $50 million through a capped non-recourse monetization of Jemperli royalties as well as share incremental data from the imsidolimab Phase 3 program.”
Updates on Wholly Owned Immune Cell Modulator Pipeline
ANB032 (BTLA agonist antibody)
- Enrollment ongoing for global Phase 2b trial in moderate-to-severe 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
- Reiterating top-line Week 14 data anticipated by year-end 2024
- Primary endpoint in Phase 2b trial to be updated from absolute change in EASI score to EASI-75 at Week 14, which is a well-accepted registrational endpoint that enables more relevant comparisons to benchmark therapies
- Presented posters on previously reported ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function and preclinical graft vs. host disease (GvHD) data at the 2024 American Academy of Dermatology (AAD) Annual Meeting in March 2024 and American Association of Immunologists (AAI) Annual Meeting in May 2024
- Poster presentations are 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