A Phase 2 clinical trial, NOBILITY, evaluating Roche’s (OTCQX:RHHBY) Gazyva (obinutuzumab) in patients with lupus nephritis, severe kidney inflammation related to autoimmune disorder systemic lupus erythematosus, met the primary endpoint.
Specifically, a statistically significantly greater proportion (40%) of patients receiving Gazyva + standard-of-care (SOC) treatment achieved complete renal response compared to placebo + SOC (18%) (p=0.007).
Key secondary endpoints were also met.
No new safety signals were observed.
A Phase 3 trial should launch in 2020.
Obinutuzumab is an engineered monoclonal antibody that binds to a surface protein found on certain types of B cells called CD20. The company says it is believed to work by attacking cancer cells in conjunction with the body’s immune system.
Gazyva is currently approved in the U.S. for a range of blood cancers.
Related ticker: Biogen (BIIB -0.1%)
The company will host a conference call tomorrow, November 12, at 10:30 am ET to discuss the results.
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