Kezar Life Sciences ( KZR Quick Quote KZR - Free Report) announced promising top-line data from a phase II study — MISSION — evaluating its lead pipeline candidate, zetomipzomib — a novel, first-in-class selective immunoproteasome inhibitor, in patients with active lupus nephritis (LN), a type of kidney disease caused by the autoimmune disease systemic lupus erythematosus (SLE) or lupus.
The LN disease can lead to an increased risk of end-stage renal disease, requiring dialysis or renal transplantation and an increased risk of death.
Data from the MISSION study showed that treatment with zetomipzomib led to 64.7% of active LN patients in the study achieving an objective response rate, as measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) from baseline at six months. Moreover, 35.2% of patients achieved a complete response rate (CRR) with a UPCR of 0.5 or less.
The benefits achieved with zetomipzomib therapy were maintained or deepened following the end of treatment at week 25. At week 29, 94.1% of study patients achieved an ORR and complete response was sustained in patients who achieved CRR at six months.
The treatment with zetomipzomib also led to a decline in mean daily prednisone background dosage of 52.6% from baseline after six months of treatment, which was further reduced at week 29. The mean estimated glomerular filtration rate, a measure of kidney function, was also stable compared to baseline. The candidate was also well tolerated in active LN patients over the course of the treatment period. The candidate has all important attributes to be a potential effective treatment for patients with autoimmune disease who are often young and active.
Data from the MISSION study demonstrates the potential of zetomipzomib in achieving a clinically meaningful overall renal response to zetomipzomib after six months without high-dose induction therapy — typical of current treatment options.
Currently, there are very few treatment options available for active LN patients, who bear a risk of considerable morbidity. The promising study data on zetomipzomib implies a strong opportunity for the candidate in this patient population, following successful development and potential approval.
Shares of Kezar surged 102.6% during after-hours trading on Jun 27, following the positive data readout. However, shares of the company have declined 65.4% so far this year compared with the
industry’s decrease of 21.7%. Image Source: Zacks Investment Research
Based on encouraging data from the MISSION study, Kezar is planning to continue the development of zetomipzomib for patients with LN, as well as evaluate development opportunities for SLE.
Apart from LN, Kezar is also developing zetomipzomib as a potential treatment for active dermatomyositis (DM) or polymyositis (PM). Data readout from another mid-stage study, PRESIDIO, last month showed that treatment with the candidate clinically meaningful improvements in total improvement score in DM and PM patients. However, it failed to significantly differentiate from the placebo. Kezar has another candidate, KZR-261, in its pipeline, which is being evaluated in a phase I study in patients with locally advanced or metastatic solid malignancies.
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