Setback for Kezar Life Sciences’ Lupus candidate zetomipzomib

California, USA-based biotech Kezar Life Sciences (Nasdaq: KZR) saw its share tumble more than 42% to 40.77 yesterday, after it revealed it was voluntarily pausing enrollment of new patients and dosing of ongoing patients in the Phase IIb PALIZADE clinical trial, pending further evaluation.

PALIZADE is a global, placebo-controlled, randomized, double-blind Phase IIb clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib in patients with active lupus nephritis (LN). Patients in the trial are randomly assigned (1:1:1) to receive 30mg of zetomipzomib, 60mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy.

Kezar has suspended enrollment and dosing in PALIZADE at the recommendation of the IDMC after its recent review of emerging safety data, including an assessment of four Grade 5 (fatal) serious adverse events (SAEs) that have occurred during the course of the trial in patients enrolled in the Philippines and Argentina.