Kezar's Autoimmune Medication Faces Second FDA Clinical Hold Within Two Months

Kezar’s Autoimmune Medication Faces Second FDA Clinical Hold Within Two Months

Kezar's Autoimmune Medication Faces Second FDA Clinical Hold Within Two Months

Kezar Life Sciences is facing ongoing challenges this fall with its autoimmune treatment candidate, zetomipzomib. Just over a month after the FDA placed a clinical hold on the use of zetomipzomib for lupus, the agency has now instituted a partial hold on a mid-stage trial regarding its use in autoimmune hepatitis, as noted in the company’s Q3 business update released Tuesday.

In the previous month, Kezar opted to terminate its lupus program after the occurrence of four patient fatalities during the Phase IIb PALIZADE trial. As a result, a partial clinical hold has been imposed, preventing the last four patients in the double-blind treatment phase (DBTP) of the Phase IIa PORTOLA trial in autoimmune hepatitis from advancing to the open-label extension. Nevertheless, the FDA has permitted enrolled participants to finish their 24-week DBTP and allows those already in the open-label extension to continue their treatment.

William Blair analysts observed in an investor note Wednesday that “This extra precaution was implemented to ensure that any potential placebo patients remaining in the DBTP would not receive zetomipzomib, even though the IDMC has recommended that the PORTOLA trial continue without any reported adverse events of significance or deaths as occurred in the PALIZADE trial.” Kezar confirmed that no Grade 4 or 5 serious adverse events have been reported in the PORTOLA trial.

The company expects to unveil topline data from the PORTOLA trial in the first half of 2025. Analysts from William Blair highlighted the critical nature of this upcoming release, stating, “Given the discontinuation of the PALIZADE study during the quarter, we have significant reliance on positive outcomes from the PORTOLA study in early 2025 to help boost share value.”

Kezar’s stock performance this year has fluctuated significantly, plummeting from a peak of .50 per share in February to a bottom of .20 in September. As of Wednesday morning pre-market trading, the company’s shares were valued at .28 per share.

Kezar’s CEO, Chris Kirk, highlighted in October that the choice to cease the lupus program was challenging given the favorable safety profile and clinical activity identified in an earlier study, MISSION. “However, shifting our developmental focus to autoimmune hepatitis allows us to extend our financial resources and provides flexibility as we advance zetomipzomib as a potential therapy for patients facing this serious condition,” Kirk stated in a press release.

As of September 30, Kezar reported having 8 million in cash, cash equivalents, and marketable securities.