Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD

O que extraímos desta fonte

The claims Via News extracted from this document. We point to the source; we don't replace it.

• ZB021 is a novel, potentially best-in-class, oral small molecule IL-17AA/AF inhibitor

  60% confidence

• The INDIGO open label extension will further build upon the largest body of clinical data reported for IgG4-RD patients to date

  60% confidence

• Obexelimab met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints in INDIGO and was generally well tolerated

  60% confidence

• Obexelimab demonstrated a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.44, p=0.0005) during the 52-week randomized placebo-controlled period of INDIGO

  60% confidence

• Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor that targets pathogenic B cells in both the periphery and CNS, and directly modulates macrophages and microglial cells, with potential to address compartmentalized inflammation and disease progression in MS

  60% confidence

• The BLA submission brings Zenas one step closer to delivering a meaningful treatment option to patients living with IgG4-RD; based on INDIGO clinical activity and safety profile, obexelimab may have an important role as a first-line therapy in long-term management of IgG4-RD

  60% confidence

• Obexelimab has been evaluated in eight clinical trials in a total of 383 subjects, including INDIGO, and was well tolerated with demonstrated clinical activity across all trials

  60% confidence

• ZB022 is a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor

  60% confidence

• Zenas expects to report topline SLE Phase 2 trial results, including biomarker data, in the fourth quarter of 2026

  60% confidence