Vital Therapies ELAD System Fails in Phase III Trial, Stocks Plunge
Published: Sep 12, 2018 By Alex Keown
Shares of San Diego-based Vital Therapies have plunged more than 88 percent in premarket trading after the company announced that its Phase III liver disease treatment failed to improve overall survival in patients. This failure marked the second time Vital’s program failed.
The VT-308 trial failure was so dramatic, that Vital is pulling the plug on the liver disease program and will explore strategic options. Vital did not provide much in the way of trial data when announcing its decision this morning. The VT-308 trial was a randomized, open-label study for the treatment of severe alcoholic hepatitis. Alcoholic hepatitis is an inflammation of the liver caused by drinking alcohol. The trial included 151 patients, 78 in an ELAD-treated arm and 73 in control arm, Vital noted in its second quarterly report, which was announced last month.
Vital said its ELAD program, a cell-based therapy targeting acute forms of liver failure, failed to meet its primary endpoint of being capable of demonstrating a significant improvement in overall survival through at least 91 days of treatment. Additionally, the ELAD program failed to meet the secondary endpoint of demonstrating a statistically significant difference in the proportion of survivors at 91 days between the different treatment groups.
“In light of these results, the Company does not believe the ELAD System can be approved in the United States or European Union, if ever, without additional clinical trials that would require substantial capital and time to complete,” Vital Therapies said in its announcement this morning.
The ELAD System is designed to promote the recovery and regeneration of the patient’s failing liver, and potentially increase the rate of survival, according to company data.
Vital Therapies Chief Executive Officer Russell Cox thanked the trial participants in a brief statement and did not elaborate on what strategic options the company may explore in the wake of the ELAD failure.
This morning’s announcement marks the second time the ELAD program has crashed and burned at Vital. In 2015 the company’s liver disease program also failed to meet primary and secondary endpoints. Like this morning’s trial announcement, in 2015 data showed there was no statistical significance in survivability between the treatment group and the control group, the company said. Secondary endpoints of proportions of survivors also showed no statistical significance.
With the news, investors in Vital Therapies are dumping the stock. The price plunged from Tuesday’s close of $6.40 to 70 cents per share in early trading. Last month the company reported it had cash and cash equivalents of $31.1 million, as of June 30.