Kezar Life Sciences, Inc. (NASDAQ:KZR) Q3 2019 Earnings Conference Call - Final Transcript
Nov 12, 2019 • 08:30 am ET
gene expression level is a very broad immunomodulatory activity following KZR-616 administration. This leads to a decrease in acute inflammatory cytokines produced from the innate immune system cells such as macrophages and dendritic cells, skewing of T cells away from inflammatory Th1 and Th17 phenotypes and increasing the number of regulatory T cells with circulation and finally decreasing the plasma blast activation and plasma cell survival both directly and indirectly with hoping in a reduction in auto antibodies.
So with that, I'm going to dig into the MISSION study. Let me give you a reminder of the study design of this open-label study in non-renal lupus patients. We present -- those who've been following the story know that we presented data from our first two cohorts at EULAR with updated data being presented here today. This was a study of weekly administration of KZR-616 for three months. Patients were on a stable background medication one month prior to and while on KZR-616 therapy, there was a 12-week follow-up after the last dose. This was a safety study designed to pick doses for our Phase 2 portion in patients with active lupus nephritis.
What we'll be presenting at ACR is aggregate safety data across those two original cohorts that had what we call flat dosing at either 45 milligrams or 60 milligrams plus two additional cohorts that involve the 60-milligram dose level that utilize the dose titration or step-up dosing to get patients to 60 milligrams in order to improve tolerability. We're presenting a lot of data around Cohort 2a which is a completed enrollment with treatment still ongoing, and the newly enrolled -- enrolling cohort, Cohort 2b, where we're presenting safety data here at ACR. But because patients had only achieved five months -- sorry, five weeks of dosing prior to the data cut off for ACR, there won't be any efficacy data presented from those patients today. Nonetheless, the safety data that will go into first we believe is compelling for these two cohorts.
Before we dig into the data in detail let me summarize what we've learned thus far in the study. Both the 45 milligram and the 60 milligram dose levels for KZR-616 are well tolerated for 13 weeks of treatment. We avoid the toxicity seen with agents like VELCADE and KYPROLIS. We're encouraged by the low infection rate that we see, which suggests that there might be a lack of immunosuppression with this drug as bolstered by preclinical data. Though this was not an efficacy-driven study, it was a safety-driven study. We were very happy with the breadth and depth and consistency of efficacy that we saw across the 16 evaluable patients who made it through 13 weeks of dosing at the time of the data cut off.
And let me start with the pharmacology. We saw, as we had in our healthy volunteer studies, very consistent PK across subjects and with lupus and as I will show you here, very consistent pharmacodynamics. What you're seeing