Kezar Life Sciences (NASDAQ:KZR) is up 9% after hours in reaction to data from the Phase 1b portion of the Phase 1/2 MISSION study evaluating lead candidate KZR-616 in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN). The results were presented virtually at the Pan-American Congress on Rheumatology.
As of May 4 data cutoff, 39 participants were enrolled across five dose cohorts evaluating 45 mg and step-up dosing to 60 mg for 13 weeks. Patients were followed to week 25 and kept on stable background treatment. At this time point, 22 patients completed 13 weeks of treatment.
At week 13, five patients with increased DNA antibodies (biomarkers of SLE disease activity) experienced reductions from -6.3% to -76.7%. At week 25, the reductions ranged from -18.8% to -82.0%.
Two of two patients with active proliferative LN experienced more than 50% decreases from baseline in proteinuria, a biomarker of disease severity.
On the safety front, most treatment-related adverse events were mild or moderate. The most common were transient injection site reactions.
KZR-616 is a immunoproteasome inhibitor that the company says delivers a broad anti-inflammatory response and has shown potential efficacy in reducing the severity of certain autoimmune diseases (e.g., lupus, rheumatoid arthritis, IBD, MS, type 1 diabetes) in animal models.
The study is ongoing. The estimated primary completion date is June 2021.
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