Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.
Kezar Life Sciences is laying off nearly three-quarters of its workforce after the company failed to square things away with the FDA on plans for its investigational autoimmune hepatitis drug.
Kezar is letting go of 31 employees, according to an SEC filing on Monday. That would represent about 70% of its staff. The move will cost Kezar about $6 million in one-time fees, which will go on the balance sheet in the fourth quarter.
In October, Kezar announced it was planning layoffs after the FDA canceled a fourth-quarter Type C meeting to discuss a study of the company’s zetomipzomib, a small molecule therapy for patients with relapsed and refractory autoimmune hepatitis.
According to analysts from William Blair, the FDA suggested that Kezar test zetomipzomib in a stand-alone trial rather than a pivotal trial design, a change of plans that could delay future development of the drug by two years.
“Given resource constraints, Kezar management is exploring strategic alternatives,” the analysts wrote. “With the positive Phase II trial results in AIH and what we continue to believe is a tolerable safety profile in patients not on background high-dose steroids, we are surprised to see the FDA refusing to host a Type C meeting, particularly after the Division of Hepatology and Nutrition lifted the prior partial clinical hold in July.”
Last fall, the FDA placed two separate clinical holds on zetomipzomib. The first hold came after four patients died in a Phase IIb trial testing the drug in lupus. Kezar subsequently discontinued its lupus program. The second partial hold, which came a month later, was placed on the hepatitis program, blocking four other patients from proceeding in a separate Phase IIa trial. The FDA lifted that hepatitis hold in July.
“We continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with AIH,” CEO Chris Kirk said in a statement at the time. “We look forward to engaging with the FDA to align on the design of the next clinical trial of zetomipzomib in AIH.”
That alignment has evidently still not happened.
According to an Oct. 16 filing with the SEC, the company had about $90.2 million in cash, cash equivalents and other securities as of Sept. 30.
Also on Monday, Kezar presented data from its Phase IIa trial of zetomipzomib in AIH, showing that 36% of patients achieved biochemical remission and were able to taper steroid use, compared to no patients in a placebo arm.
Kezar’s stock is down about 17% in the past year since the company’s troubles with zetomipzomib began.
