Vital Therapies has built its whole operation upon the cell-based treatment for acute liver failure it calls ELAD. That foundation has now collapsed.
The San Diego-based biotech announced that ELAD failed both primary and secondary endpoints in a Phase III trial, showing no significant improvement in overall survival or proportion of survivors at study day 91 for patients with severe alcoholic hepatitis. Seeing no short path to approval, Vital has decided to “cease any further development of the ELAD System and explore strategic options.”
Investors followed the therapy out the door, sending Vital shares $VTL down more than 88% in pre-market trading. It’s now trading at $0.70, a fraction of its IPO price in 2014.
Some may have seen this coming. Vital pushed its way into Phase III clinching a post hoc subset analysis of an otherwise failed Phase II study, which convinced execs they stood a good chance of success if they only focused on younger patients with a less severe form of the disease.
The year was 2015, and the company had $62 million in the bank to complete a new trial, meant to yield results that would support a BLA filing in 2019. As of June 30, $31.1 million of that remained intact, which they expected to last until the first quarter of 2019.
ELAD, short for extracorporeal liver assist system, features human liver-derived cells and a device to pump the patient’s blood through these VTL-C3A cells, then back to their body. Vital once drummed up hopes for the drug-device in other indications — acute flares of viral hepatitis B, transplant settings, and post-surgical maintenance for liver cancer patients.
“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,” said CEO Russell Cox, a Jazz Pharma vet who took the helm just before the trial launched.
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