Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Feb 25
- 1 min read
24/02/2026
Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis (Ref)
Abcuro announced topline results from its Phase 2/3 MUSCLE/ NCT05721573 study, which evaluated ulviprubart (ABC008; anti-KLRG1) for the treatment of patients with inclusion body myositis (IBM)
The MUSCLE study did not meet its primary or key secondary endpoints
Clinically meaningful slowing of disease progression was observed in patients with mild to moderate disease; this established a basis for advancing ulviprubart in this segment of the population
Ulviprubart demonstrated a favorable safety and tolerability profile compared to placebo, and no safety signals were identified at the doses studied
Abcuro planned to present the results of the MUSCLE trial at the upcoming 6th Global Conference on Myositis (GCOM) meeting
J&J submitted sBLA to the US FDA for approval of IMAAVY® for warm autoimmune hemolytic anemia (Ref)
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US FDA for approval of IMAAVY® (nipocalimab-aahu; FcRn antagonist) for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA)
The sBLA was supported by the Phase 2/3, ENERGY/ NCT04119050 study, which evaluated nipocalimab in wAIHA
The data showed that more patients treated with nipocalimab achieved the primary endpoint of a durable hemoglobin response compared with placebo
Patients treated with IMAAVY® also showed rapid and sustained improvements in hemoglobin and fatigue as assesses by FACIT-Fatigue
