Vital Returns To Drawing Board After Phase III Trial Flops

San Diego-based Vital Therapies has stopped all developments of its ELAD System after a Phase III trial flopped, sending the company’s stock on a downward spiral.

Vital Therapies’ stock fell by almost 89 percent since Tuesday when the company announced its Phase III trial results, falling from $6.30 to 70 cents in early trades.

Vital said it was exploring its strategic options after ELAD, the company’s cell-based therapy for treating liver failure, did not meet the study’s primary goal of improving survival rates in patients.

The company said its study “failed to meet the primary endpoint of a significant improvement in overall survival through at least 91 days 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.”

Vital said it did not believe the ELAD System could get U.S. or European Union approval without further “clinical trials that would require substantial capital and time to complete.”

The trials were performed on 151 patients.

The ELAD System, which was was designed to promote the recovery and regeneration of the patient’s failing liver, with the potential to increase the rate of survival, was in trials to treat severe alcoholic hepatitis, an inflammation of the liver caused by drinking alcohol.

There had been optimism that the company’s therapy, VTL-380 would succeed after previous failure in 2015. So high was the optimism that the Motley Fool website rated Vital as one of the biotech companies that could double an investor’s stock. An analysis by Cantor Fitzgerald had speculated on Vital’s Phase III trial and concluded that the “odds of success seem awfully high.”

It is estimated that up to 100,000 Americans are diagnosed with alcoholic hepatitis annually, 80,000 suffer from other acute forms of liver failure.

The digital transformation of healthcare is very much needed with a growing population and increased prevalence of disease. Although Vital is back to the drawing board with its ELAD System, many healthcare startups are hard at work delivering innovative treatment options to patients in need.

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