- Full Results Presented at European Association for the Study of the Liver
Annual Meeting -
SAN FRANCISCO, April 24 /PRNewswire/ -- Antipodean Pharmaceuticals, Inc. announced today, at the European Meeting for the Study of the Liver (EASL), the positive results of a Phase 2 trial of its lead compound MitoQ(R) (mitoquinone) in liver disease. The trial, conducted by Dr. Edward Gane, Associate Professor of Medicine, New Zealand Liver Transplant Unit at Auckland City Hospital, successfully met the primary clinical endpoint, the reduction of elevated liver enzymes.
In the 28-day trial, 30 patients with the Hepatitis C virus (HCV) were enrolled to study the effects of MitoQ on elevated liver enzymes. Researchers measured patients' baseline levels of aminotransferase (ALT), an enzyme released into the blood that indicates damage to the liver. The double-blind trial randomized patients to one of three treatment groups: MitoQ 40mg/day, MitoQ(R) 80mg/day or placebo. The primary endpoint was the reduction of levels of ALT. Patients who received MitoQ showed a significant decrease in ALT levels at the end of the study compared with baseline levels. The decrease from baseline was 26.4% (p<0.002) for patients in the 40mg dose group, and 28% (p<0.05) for patients in the 80mg dose group. These results suggest that MitoQ can reduce necroinflammation and may halt disease progression to fibrosis or cirrhosis.
The drug was well tolerated with no significant safety issues. Commonly reported adverse events (AEs) included nausea, headache and vomiting, which were usually mild and well tolerated. Only one patient withdrew from the study due to nausea. There were no significant laboratory or ECG abnormalities observed and no serious adverse events (SAEs) were reported.
"In patients with chronic liver disease, including the two patient
populations with the largest unmet need -- patients with chronic hepatitis
C, who have failed
|SOURCE Antipodean Pharmaceuticals, Inc.|
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