Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD
View original at globenewswire.comZenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD - BLA submission based on positive results from Phase 3 INDIGO trial - WALTHAM, Mass., May 28, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc…
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The INDIGO open label extension will further build upon the largest body of clinical data reported for IgG4-RD patients to date
60% confidenceObexelimab met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints in INDIGO and was generally well tolerated
60% confidenceObexelimab 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% confidenceThe 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% confidenceZB021 is a novel, potentially best-in-class, oral small molecule IL-17AA/AF inhibitor
60% confidenceObexelimab 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% confidenceZB022 is a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor
60% confidenceOrelabrutinib 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% confidenceZenas expects to report topline SLE Phase 2 trial results, including biomarker data, in the fourth quarter of 2026
60% confidence