August 24, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN DIEGO – Vital Therapies, Inc. stock plummeted more than 77 percent after the company revealed late Friday its late stage liver therapy failed to meet its primary and secondary goals. The hit a low of $3.51 per share, down from $17.64 per share on Friday.
Vital Therapies had been studying its ELAD System, a cell-based therapy targeting the treatment alcohol-induced liver decompensation (AILD). The company announced late Friday that its Phase III VTI-208 trial failed to meet its primary endpoint of overall survivability of at least 91 days. Trial 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. The ELAD System (extracorporeal liver assist device) operates similar to a dialysis machine. An external device filters toxins in the blood that can damage liver cells and transfuses the blood back into a patient’s body.
Vital’s VTI-208 trial included 203 patients with AILD, also called alcoholic hepatitis. Alcoholic hepatitis occurs when the liver is damaged by the consumption of alcohol, although the amount necessary to consume to develop AILD differs per individual, according to the Mayo Clinic.
Just a few weeks ago, Terry Winters, Vital’s chief executive officer, said the company had enough cash on hand to fund Vital through the third quarter of 2016, largely dependent on positive results of VTI-208.Al Kildani, vice president of investor relations at Vital Therapies, said at this time he is unable to comment on whether or not the company would undertake any sort of corporate restructuring that could result in layoffs due to the trial’s failure.
In June, Vital reported a net loss and net loss attributable to common stockholders of $15.1 million for the second quarter, largely due to an increase in R&D costs.
Vital Therapies said that while the trial failed to meet its goals, the company was encouraged by some of the results it had seen, particularly with one cohort of patients with a MELD score of less than 28. Data showed that patients in the trial under 46.9 years of age had a hazard ratio of 0.634 with a log-rank p-value of 0.167, which suggests that future trials may incorporate stratification by age.
Vital Therapies’ ELAD System had been assigned Orphan Drug Status by the U.S. Food and Drug Administration (FDA) due to the mortality rate of acute liver failure. Currently there are no treatments to prolong survival rates, Reuters reported.
In addition to the VTI-208 trial, Vital Therapies said it will stop two other trials, the VTI-210 study, which included 150 patients and was in late stages of evaluating the ELAD System’s treatment of acute alcoholic hepatitis, and the VTI-212, which was enrolling patients with acute liver failure for a mid-stage study.
Vital Therapies said it will stop the VTI-210 and VTI-212 clinical trials, and also plans to meet with the FDA as soon as possible to discuss restructuring its clinical development program, including a potential new trial to confirm the information suggested by the subset analyses. The company said it has $62 million in available funding to launch a new trial, but that would be subject to regulatory authorities.
Vital Therapies will host a conference call at 5 p.m. EST today to discuss the results of the trial’s failure.
