FDA Issues Second Clinical Hold on Kezar’s Zetomipzomib Program Within Two Months

Clinical Hold on Lupus Nephritis Program:
The FDA placed a clinical hold on Kezar Life Sciences' zetomipzomib program for lupus nephritis due to four patient deaths during the Phase IIb PALIZADE trial23.

Termination of Lupus Program:
Following the clinical hold and recommendations from an independent data monitoring committee, Kezar discontinued the lupus program to focus on developing zetomipzomib for autoimmune hepatitis2.

Partial Clinical Hold on Autoimmune Hepatitis Trial:
The FDA issued a partial clinical hold on the Phase IIa PORTOLA trial for autoimmune hepatitis, preventing four patients from moving to the open-label extension portion of the trial. However, the trial will continue as planned for other participants5.

Future Plans:
Kezar plans to report topline data from the PORTOLA trial in the first half of 2025, emphasizing the importance of positive results to reverse the decline in share price5.

Financial and Strategic Considerations:
The decision to focus on autoimmune hepatitis extends Kezar's cash runway and provides flexibility in developing zetomipzomib. The company had $148 million in cash, cash equivalents, and marketable securities25.

Sources:

2. https://www.biospace.com/drug-development/kezar-cuts-lupus-program-after-patient-deaths-focuses-on-autoimmune-hepatitis

3. https://www.lupus.org/news/update-fda-places-kezar-life-sciences-phase-2b-study-of-zetomipzomib-for-lupus-nephritis

5. https://www.biospace.com/fda/kezars-autoimmune-drug-hit-with-second-fda-clinical-hold-in-as-many-months