On Friday, Kezar Life Sciences Inc. (NASDAQ:KZR) announced that it was informed via teleconference with the FDA that the zetomipzomib Investigational New Drug (IND) application for lupus nephritis (LN) has been placed on clinical hold.
Lupus nephritis is a type of kidney disease caused by systemic lupus erythematosus link (SLE or lupus).
Lupus is an autoimmune disease link—a disorder in which the body’s immune system attacks the body’s cells and organs.
The action follows Kezar’s communication to the FDA that Kezar was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE trial of zetomipzomib in lupus nephritis patients at the recommendation of the trial’s Independent Data Monitoring Committee (IDMC).
The IDMC’s recommendation followed their review of emerging safety data, including an assessment of four Grade 5 (fatal or death) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina.
The FDA indicated they will provide Kezar with an official clinical hold letter within 30 days.
“At this time, our zetomipzomib IND for autoimmune hepatitis is unaffected. Our Phase 2a PORTOLA clinical trial of zetomipzomib in patients with autoimmune hepatitis remains active, and we have not observed any Grade 4 or 5 SAEs in the PORTOLA trial to date,” said Chris Kirk, Kezar’s CEO.
In its second-quarter earnings release, Kezar Life Sciences announced that it had dropped its phase 1 solid tumor drug.
The company said it stopped patient enrollment in the KZR-261 Phase 1 study, and clinical resources are being reallocated toward developing zetomipzomib in autoimmune hepatitis and lupus nephritis.
The company expected to share topline data from the Phase 2b PALIZADE trial in mid-2026.
Price Action: At last check on Monday, KZR stock was down 0.54% to $0.79 during the premarket session.
Price Action:
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