Vital Therapies under investigation for undisclosed information from phase 2 study

Block & Leviton LLP announced it is conducting an investigation of various officers and directors at Vital Therapies who may have violated federal securities laws in connection with how results of its VTI-206 study were presented to investors, according to a press release.

The release states that the law firm began its investigation after an analyst report published in Seeking Alpha on July 14 indicated the company misled investors with how the company represented the 90-day overall survival rate for those treated with its Extracorporeal Liver Assist Device (ELAD, Vital Therapies), a cell-based therapy that targets liver failure. The report stated the results were “highly misleading,” because the survival data reported was from a patient who received a liver transplant and the company had no patient in the control group who had received a transplant.

The report further stated that the differences in the patients was not disclosed in any of the company’s prior communications, according to the release.

Shares of Vital Therapies have decreased by 16%, a loss of approximately $85 million on July 15, according to the release.

In the phase 2 study, which has been completed, 62 patients with alcohol-induced liver decompensation were included and used the ELAD system, according to the Vital Therapies website.

The website states that ELAD is an investigational extracorporeal, human cell-based liver support system designed with the proposed intent to supplement hepatic function in order to improve survival rates among subjects with liver failure. The device incorporates human liver-derived cells, or VTL C3A cells, contained in four hollow fiber cartridges that are combined with single use customized disposable sets and a reusable ancillary delivery system.

Vital Therapies did not respond to a request for comment from Healio.com/Hepatology by the time of publication.