Kezar Highlights Data from MISSION Phase 1b Study of KZR-616 during the Pan American Congress of Rheumatology - Seite 2

Treatment
(Week 13)

End of
Study
(Week 25)

Patient A

1015

-64.0

-82.0

Patient B

87

-20.7

-33.3

Patient C

32

-6.3

-18.8

Patient D

134

-60.4

-54.5

Patient E

90

-76.7

-68.9

As previously reported:

• Notably, two of two patients with active proliferative LN, despite being on stable background therapy, saw a greater than 50% decrease from baseline in proteinuria, a biomarker of disease severity. Both patients also experienced reductions in SLEDAI-2K and reductions in anti-dsDNA (double-stranded DNA) antibody levels.
• Among patients completing treatment, all seven measures of disease activity improved (decrease in score) in the majority of patients from Baseline to Week 13. Improvement in disease activity persisted following the end-of-treatment.
• Step-up dosing of KZR-616 improved overall tolerability. Most patients had mild (87.2%) or moderate (30.8%) TEAEs, which occurred early and diminished with later doses. The most common treatment emergent adverse events were transient injection site reactions.
• To date, no patients have discontinued treatment in Cohorts 2b and 2c, which utilize a lyophilized formulation of KZR-616.

About MISSION

MISSION (NCT03393013) is a Phase 1b/2 clinical trial evaluating KZR-616 in SLE patients with and without nephritis. The study consists of two parts. The Phase 1b portion is an open-label dose escalation study which is evaluating doses up to 75 mg of KZR-616 across 6 cohorts, which has completed enrollment. The primary objective of the Ph1b portion of MISSION is to assess safety and tolerability. Secondary objectives include evaluating pharmacokinetics (PK) and pharmacodynamics (PD) and selecting dose levels for the Phase 2 trials. Several exploratory efficacy measures are also being assessed: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), Cutaneous Lupus Erythematosus Severity Index-Activity (CLASI-A), Tender and Swollen Joint Counts (TJC/SJC), Physician Global Assessment (PhGA), Patient Global Assessment (PtGA) and Patient Assessment of Pain (PtP). The Phase 2 portion of the MISSION study evaluating KZR-616 in patients with LN is currently enrolling.