Vital Therapies (NSDQ:VTL) outlined plans for a possible new phase 3 clinical trial to test its Elad treatment for liver failure in patients with alcohol-induced liver decompensation, according to an SEC filing posted yesterday.
The company is developing a cell-based therapy targeting the treatment of acute liver failure, using a cartridge system designed to produce cells that mimic those of a patient’s liver.
San Diego-based Vital Therapies halted a Phase III clinical trial of the Elad cell-based treatment for liver failure after it failed to meet its primary and secondary endpoints and shut down 2 other studies.
The plans for the new trial are based on “trends identified in pre-specified and post-hoc subset analyses of the subjects in the company’s recently completed VTI-208 phase 3 clinical trial,” according to the SEC filing.
Earlier this month, the company said it plans to lay off 32 employees, or about 30% of its workforce, and slash expenses as it looks to reboot its clinical program after the failure its Elad device in a trial last month.
The 203-patient VTI-208 trial, examining the efficacy of the cell-based therapy in treating subjects with alcohol-induced liver decomposition, found no difference between the control group and those treated with Elad in the primary endpoint of overall survival of at least 91 days. Secondary survival endpoints, at 28 and 91 days, and serious adverse events were also equivalent.
Vital Therapies said the layoffs, slated to be complete by the end of the year, are expected to cost $1.2 million during the 3rd quarter, including $900,000 in severance benefits.