Vital Therapies Announces Trial Failure For Patients With Liver Failure
Shares of Vital Therapies (VTL) tumbled 75% in after-hours trading after the company announced that its VTI-208 trial failed in a pivotal phase 3 trial. The company attempted to use its ELAD System to act as a cell-based liver support system for patients with alcohol-induced liver decompensation (AILD).
The trial enrolled 203 patients who either took ELAD or a control for the trial. The trial failed to meet on the primary endpoint which was to improve overall survival through 91 days, using a scale known as Kaplan Meier Statistical Method.
The trial also failed on the secondary endpoint. It showed no difference between ELAD and the control group in a value score known as the Pearson's Chi-Squared P-values. On day 28 of the trial the p-value was 0.45 and on day 91 the p-value was 0.74, both of which do not fall within the normal p-value range of .05 or lower, meaning the secondary endpoint was not statistically significant either.
There was an exploratory subset of 120 patients who may have benefited from the therapy. Now the company must analyze the remaining data in the coming months and meet with the FDA to determine if they can continue with another trial. Should Vital need to run another trial, it has $66 million in cash, so it can, without the need to raise any additional capital. Again this is not guaranteed but possible depending how the FDA responds.
Disclosure: None.