Vital Therapies' VTL-308 Fails To Meet Goals; To Stop ELAD System's Development

(RTTNews) - Vital Therapies, Inc. (VTL), a biotherapeutic company developing ELAD, a cell-based therapy targeting the treatment of acute forms of liver failure, announced Wednesday topline results of VTL-308 failed to achieve primary and secondary endpoints of improvement in survival. The company will cease any further development of the ELAD System and explore strategic options.

In pre-market activity on the Nasdaq, Vital Therapies shares plunged around 82 percent to $1.15. The shares had declined around 9.4 percent on Tuesday's regular trading.

In its statement, the company noted that, while there was a numerical improvement in survival in the ELAD-treated group between three months and one year following randomization, the VTL-308 study failed to meet the primary endpoint of a significant improvement in overall survival through at least 91days assessed using the Kaplan Meier statistical method.

The secondary endpoint of proportion of survivors at study day 91 also showed no statistically significant difference between the 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.

Russell J. Cox, the Company's Chief Executive Officer, said, "Although we did not achieve the outcome we were hoping for, we would like to thank those who made this trial possible, including our investigators and their staffs, the patients who were enrolled and their families, and all Vital Therapies employees."