AnaptysBio is dropping its atopic dermatitis (AD) drug candidate after the compound failed to reduce eczema area and itch severity in a phase 2b trial, missing all of its endpoints.
The ARISE-AD trial enrolled 201 patients to test ANB032, an antibody designed to target B- and T-lymphocyte attenuator (BTLA) protein to stymie immune cells and reduce inflammation.
By week 14 of the trial, the trial had failed to hit its primary endpoint, the proportion of patients who achieved at least a 75% improvement from baseline in Eczema Area and Severity Index score, or any of its secondary endpoints, including a four-point reduction in itch severity as measured by the Pruritus Numerical Rating Scale.
ANB032 approached the minimum target absolute response rates on key endpoints, but was challenged by better-than-average placebo performance, especially at U.S. sites, Anaptys said in the release.
“While ANB032 was safe and well tolerated, we’re disappointed by these efficacy results in AD and will discontinue further investment in this asset,” Anaptys president and CEO Daniel Faga said in a Dec. 11 release. “Moving forward, our resources and capital will be focused on the rest of our exciting autoimmune portfolio.”
One patient given ANB032 had a serious adverse event (SAE) of worsening AD, and two placebo patients also had SAEs, the company said. There was no relationship between dose and the occurrence of adverse events, and the most common side effects were nasopharyngitis, atopic dermatitis and headache, according to the release.
The San Diego-based biotech is expecting topline data from a phase 2 rheumatoid arthritis trial of its PD-1 agonist rosnilimab in February 2025, with ulcerative colitis data to follow in the first quarter of 2026, according to the release. Phase 1 data for other inflammatory assets ANB033 and ANB101 is also expected in 2026.
Anaptys has about $415 million in the bank and is extending its cash runway guidance through the end of 2027, the firm said in the release, excluding potential milestone and royalty payments from its immuno-oncology partnership with GSK.