The conference’s focus this year is “Artificial and Bio-artificial Liver Support-Mechanisms of Action and Clinical Effects.” Topline data from the VTI-208 clinical trial, which failed to reach its primary or secondary endpoints, was disclosed earlier on August 21.
For some background information on Vital Therapies, it is a biotherapeutic company developing a cell-based therapy targeting the treatment of liver failure. The company’s ELAD System, is an extracorporeal human allogeneic cellular liver therapy. The company is based in San Diego, California.
Vital Therapies gave a few of the major points from this additional data:
- A review of baseline characteristics and demographics of two of the pre-specified subsets: subjects with baseline Model for End-stage Liver Disease (MELD) score under 28, and age less than the median.
- A post-hoc analysis using log-rank statistics of the Kaplan Meier survival curves up to study day 91 (which was a pre-specified sensitivity analysis in the intention-to-treat, or ITT, and per protocol, or PP, populations), applied to the 59 subject (ELAD N = 26, Control N = 33) combination of these two pre-defined subsets (MELD less than 28 and age less than the median of 46.9 years), revealed no deaths in the ELAD group and eight deaths in the Control group. Had this combination been pre-defined, the p-value would have been <0.01.
- The company continues analyzing the entire VTI-208 data set in order to determine the potential next steps in clinical development. In particular, the company is exploring the design of a new phase 3 clinical trial, which limits patients based on both MELD and age. The company will provide periodic updates on material developments.
Shares were up 21.1% at $4.13 Monday morning. The stock has a consensus analyst price target of $12.00 and a 52-week trading range of $2.81 to $29.67.
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