SAN FRANCISCO, June 3 /PRNewswire/ -- Antipodean Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Investigational New Drug (IND) application for its lead compound, MitoQ(R). With the IND acceptance, the Company will involve U.S. clinical centers in the development of MitoQ for the treatment of liver diseases such as non-alcoholic fatty liver disease (NAFLD).
"We look forward to working with FDA to further explore MitoQ's potential by conducting further trials in the United States," said Ken Taylor, Ph.D., Chief Executive Officer of Antipodean Pharmaceuticals. "The Company is actively seeking a pharmaceutical partner with whom to work to achieve this goal."
In April 2008, the Company announced positive results of a clinical study of MitoQ in patients with Hepatitis C virus (HCV) who had failed standard antiviral treatment. The data from this Phase 2 trial were presented at the European Association for the Study of Liver (EASL) conference. Results showed a significant reduction in elevated alanine aminotransferase (ALT) levels as compared to placebo. The ALT decrease from baseline was 26.4% (p<0.002) for patients in the 40mg dose group. This suggests that MitoQ can reduce necroinflammation and may halt disease progression to fibrosis or cirrhosis. The drug was well tolerated, with no significant safety issues.
MitoQ is a mitochondria-targeted antioxidant that selectively blocks mitochondrial oxidative damage and prevents liver cell apoptosis. MitoQ is based on a novel technology, targeted lipophilic cations that transport and concentrate antioxidants into the mitochondria-organelles inside cells that provide energy for life processes -- where they accumulate up to a thousand fold. MitoQ can reduce the hepatic oxidative damage that is induced by viral infection and that is also involved in the progression of Non-alcoholic Fatty Liver Disease (NAFLD) through to Non-alcoholic Steatohepatitis (NASH), leading to fibrosis or cirrhosis.
About Non-alcoholic Fatty Liver Disease (NAFLD)
Symptoms of NAFLD include fat deposits, inflammation of the liver, and elevated liver enzymes -- ALT and AST. As with Hepatitis C, oxidative stress is involved in NAFLD disease progression to fibrosis and cirrhosis. NAFLD affects approximately 20% of the world's population and the incidence is growing rapidly as obesity rates rise. There are currently no satisfactory treatment options.
Antipodean is a clinical-stage pharmaceutical company developing targeted molecules that prevent oxidative damage to endothelial, epithelial and liver cells leading to apoptosis and fibrosis. The Company is developing a mitochondria-targeted antioxidant, MitoQ (mitoquinone mesylate), for the treatment of hepatic inflammatory disorders caused by oxidative stress such as NAFLD and NASH. The Company's business plan is to develop drugs to the point of proof of principle and then partner further development. Antipodean has research collaborations with pre-clinical and clinical investigators in Cambridge, UK, Auckland, New Zealand, and several centers in the US to identify and develop lead compounds through to clinical proof-of-principle. Currently the Company's lead compounds target liver and skin diseases. Antipodean is located in San Francisco, California. Further information is available at http://www.antipodeanpharma.com
CONTACT: Charlotte Merckel of Antipodean Pharmaceuticals, Inc.,
Web site: http://www.antipodeanpharma.com/