Kezar Life Sciences (KZR) Stock: Why It Surged 43.43%

By Amit Chowdhry ● Jun 29, 2022
  • The stock price of Kezar Life Sciences Inc (NASDAQ: KZR) increased by 43.43% in the previous trading session. This is why.

The stock price of Kezar Life Sciences Inc (NASDAQ: KZR) – a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders – increased by 43.43% in the previous trading session. Investors are responding positively to Kezar Life Sciences reporting positive topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib, a novel, first-in-class selective immunoproteasome inhibitor, in patients with active lupus nephritis (LN).

The MISSION Phase 2 clinical trial is an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN. And during the 24-week treatment period, patients received 60 mg of zetomipzomib subcutaneously once weekly (first dose of 30 mg) in addition to stable background therapy. The end-of-treatment (EOT) assessments occurred at Week 25, with completion of study at Week 37. Patients in the MISSION Phase 2 clinical trial received zetomipzomib without induction therapy, which represents a significant difference from other recently published trials in LN.

The primary efficacy endpoint for the trial was the proportion of patients achieving an overall renal response (ORR), measured as a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at EOT. And a key secondary efficacy endpoint was the number of patients with a complete renal response (CRR), measured as an absolute reduction in proteinuria values to a UPCR of 0.5 or less, with preserved renal function (eGFR), and corticosteroid use of 10 mg or less prednisone/prednisone equivalent and no use of prohibited medication.

Summary of Topline Results

In this Phase 2 topline analysis, 17 of 21 patients enrolled in the trial reached end of treatment:

1.) 11 of 17 patients (64.7%) achieved an ORR measured as a 50% or greater reduction in UPCR at EOT compared to baseline, the primary efficacy endpoint of the clinical trial.

2.) 6 of 17 patients (35.2%) achieved a CRR of 0.5 UPCR or less, with all other protocol definitions satisfied.

3.) Treatment benefit of zetomipzomib was maintained or deepened following the end of treatment, based on assessments at Week 29.

a.) 16 of 17 patients (94.1%) reached an ORR at Week 29, and 6 patients maintained a CRR.

4.) Mean daily prednisone background dosage was reduced from 19.2 mg at baseline to 9.1 mg at EOT and was further reduced at Week 29.

5.) Mean eGFR (estimated glomerular filtration rate) remained stable from baseline to EOT.

Plus exploratory measures of extra-renal disease activity associated with SLE improved in patients completing the trial. And patients showed mean reduction in key SLE disease activity scores and normalization in biomarkers consistent with reduction in SLE disease activity.

KEY QUOTE:

“The MISSION Phase 2 topline results show a clinically meaningful overall renal response to zetomipzomib after 6 months, without high-dose induction therapy. Patients in the trial also experienced reductions in extra-renal manifestations of lupus. Zetomipzomib appears to be immunomodulatory, well-tolerated and steroid-sparing – all important attributes for patients with autoimmune disease who are often young and active. Based on the strength of these results, we plan to continue developing zetomipzomib for patients with lupus nephritis, as well as evaluate development opportunities for systemic lupus erythematosus.”

— Noreen R. Henig, M.D., Kezar’s Chief Medical Officer

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.