Kezar Life Sciences Inc. (NASDAQ:KZR) has provided a data update from its Phase 1b part of the MISSION study. The study focused on evaluating the tolerability and safety of KZR-616 in the treatment of systemic lupus erythematosus (SLE) patients having nephritis and those without.
Phase 1b data showed improvement in disease activity metrics
Data from the study indicates that there were overall improvements witnessed across the seven disease activity measures. Similarly, two out of two patients having lupus nephritis demonstrated more than 50% decrease in proteinuria, which is the biomarker of the severity of the disease. Also, the data indicate a positive tolerability and safety profile witnessed when employing the drug’s step-up dosing. The dataset from the Phase 1b study builds on the comprehensive safety and tolerability Phase 1a study conducted on 100 healthy volunteers.
Noreen Henig, the company’s chief medical officer, indicated that KZR has demonstrated favorable tolerability and safety profile. The positive outcomes were at doses consistent with selective inhibition and potency of immunoproteasome activity. Henig added that there were early indications of the modification of the activity of SLE diseases. The chief medical officer added that because of the positive exploratory efficacy results, the company evaluated the possibility of bringing KZR-616 quickly to patients.
Phase 1b enrolled 39 SLE patients
The Phase 1b part of the MISSION had enrolled 39 SLE patients as of May 4 in five different dose groups. They evaluated 45mg and step-up dosing up to 60mg per week for 13 weeks. Participants are expected to be tracked up to 25 weeks and maintained on a stable treatment background.
So far, 16 participants from the five cohorts completed treatment from the 13 weeks with ten from cohort 2a and six from cohort 2b. They were also included in the exploratory efficacy study. The phase 1b included two SLE patients that had biopsy-confirmed lupus nephritis. The two patients demonstrated more than 50% proteinuria reduction as determined through urine protein to creation ratio and reduction of SLEDAI and anti-dsDNA antibody levels.