The drug is not meant to reduce liver fat. Nothing about its MoA would suggest that it does. This shouldn't have been coded as the primary endpoint and isn't in the remaining two trials. Allergan bought Tobira for massive share price premium after it missed it's primary endpoint but showed positive effects on key secondary endpoints.
The key take away is the statistically significant effect on the multitude of other key endpoints. Because most diseases have more than one consequence, many trials are designed to examine the effect of a drug on more than one endpoint. In some cases, efficacy cannot be adequately established on the basis of a single endpoint. In other cases, an effect on any of several endpoints could be sufficient to support approval of a marketing application.
- Results demonstrate excellent safety and tolerability
- Statistically significant reduction in serum endotoxin/ Lipopolysaccharide (LPS) levels compared to placebo
- Statistically significant reduction in mean serum ALT in patients with elevated pre-treatment ALT
- Statistically significant Reduction of additional serum NASH biomarkers associated with liver damage – AST and CK-18
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