AnaptysBio achieves ‘highest ever’ results in Phase II rheumatoid arthritis trial

 AnaptysBio’s Phase IIb trial of its rheumatoid arthritis (RA) treatment, rosinilimab, has seen some patients achieve the ‘highest ever’ responses at week 14, with 69% of patients achieving low disease activity.

The US-based company has announced results from its randomised RENOIR trial examining the safety and tolerability of rosnilimab (NCT06041269) in patients with moderate-to-severe RA who have until now been on conventional disease-modifying drugs.

The study achieved its primary endpoint in eliciting a mean change from baseline using the 28-Joint Disease Activity Score (DAS28-CRP) as a system of measurement, seeing statistical significance over placebo.

While the primary endpoint sought to establish safety and efficacy, secondary endpoints tracked disease progression via the mean baseline clinical disease activity index (CDAI) scale to achieve low disease activity (LDA).

Patients were split into four arms, receiving 100mg, 400mg and 600mg of rosnilimab or a placebo. Results saw not only statistical significance but also numerical significance across all dose ranges. By the end of week 14, the company stated that 69% of patients achieved LDA, the next best result besides full remission.

Anaptys president Daniel Faga said: “We are excited about these trial results and the impact they could have on patients living with RA. Rosnilimab is safe and well tolerated with the highest ever reported CDAI low disease activity at three months that, to date, is sustained and potentially deepening over six months.

“These findings are further supported by objective translational data and surpass our target product profile in the $20bn US RA market."

Faga added that in Q2 2025, the company intends to report full six-month data and additional translational data it anticipates will further substantiate rosnilimab’s impact on restoring healthy immune homeostasis in RA and additional diseases such as ulcerative colitis (UC).

https://finance.yahoo.com/news/anaptysbio-achieves-highest-ever-results-172232114.html