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KZR results-- Will this be a problem for AUPH

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lidopete   Wednesday, 06/03/20 04:56:29 PM
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Post # of 13638 

KZR results-- Will this be a problem for AUPH

The Fly
4:06 PM (49 minutes ago)
to me

KZR Alert in News Feed
See the research on theflyonthewall.com
News Breaks
June 3, 2020
16:06 EDT KZR
Kezar Life Sciences announces updated results from portion of MISSION trial
Kezar Life Sciences announced updated results from the Phase 1b portion of MISSION, which is evaluating the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus, or SLE, with and without nephritis. Overall, improvements were seen across seven measures of disease activity, and two of two patients with lupus nephritis, or LN, experienced a greater than 50% reduction in proteinuria, a biomarker of disease severity. A "positive" safety and tolerability profile was observed with step-up dosing of KZR-616. The Phase 1b dataset builds on the safety and tolerability testing performed in 100 healthy subjects from two Phase 1a studies. As of the May 4 data cutoff, the Ph1b portion of MISSION enrolled 39 SLE patients across five dose cohorts evaluating 45 mg and step-up dosing to 60 mg weekly for 13 weeks. Patients are followed to week 25 and kept on stable background treatment. Below are the results for step-up dosing Cohorts 2a, 2b, and 2c, which enrolled 26 patients. At this time point, a total of 16 patients from these cohorts completed 13 weeks of treatment and are included in the exploratory efficacy measures reported below. Two SLE patients with biopsy-proven lupus nephritis were included in the Phase 1b portion. Both patients showed a greater than 50% reduction in proteinuria as measured by urine protein to creatine ratio, as well as reductions in SLEDAI and reductions in anti-dsDNA antibody levels. Among patients completing treatment in Cohorts 2a and 2b, all seven measures of disease activity improved in the majority of patients from Baseline to Week 13. Improvement in disease activity persisted following t he end-of-treatment. Step-up dosing of KZR-616 improved overall tolerability. Most treatment emergent adverse events, or TEAEs, occurred early and diminished with later doses. To date, no patients have discontinued treatment in Cohorts 2b and 2c, which utilize a lyophilized formulation of KZR-616. The most common treatment emergent adverse events were transient injection site reactions.

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