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MitoQ® is mitoquinone formulated as a stable powder suitable for oral formulations. Antipodean has synthesized kilogram batches of MitoQ® to GMP standard and formulated a stable tablet. We have validated two analytical methods for MitoQ®. ADME and toxicology studies required for approval of our Investigational Brochure and protocol have been completed. MitoQ is rapidly distributed to all organs in the body and penetrates the blood-brain barrier. MitoQ pharmacokinetics supports a once-daily dosing schedule in humans.
MitoQ® is being evaluated as an oral treatment for liver inflammation that leads to fibrosis and is associated with metabolic dysfunction. The company is also investigating topical indications that involve mitochondrial dysfunction, including dermatologic applications and retinal degeneration.
Dr Richard Robson was the investigator for our Phase I program. Our target in Phase I was to produce MitoQ® plasma levels in the ng/ml range and this was achieved. From animal studies we can correlate such levels with effective tissue and mitochondrial concentrations of MitoQ®. The results of this study confirmed the doses for the Phase II studies.
NASH is a combination of fatty liver and inflammation of the liver. Approximately 3-5% of the US and European populations have the disease. Diet and genetic predisposition have made NASH one of the most common liver diseases in the developed world. There are no approved therapeutics for NASH. Patients are placed on weight loss and restrictive dietary programs. Oxidative stress is a key driver of the degenerative processes leading to NASH. MitoQ® is unique in its potential to restore the oxidative balance and simultaneously treat the inflammation of the liver. A Phase II proof of principle trial was completed using patients chronically infected with Hepatitis C Virus, who had liver inflammation. MitoQ® significantly reduced liver inflammation by more than 30% in treated patients. The Principal Investigator for this study was Dr Edward Gane, Associate Professor of Medicine, New Zealand Liver Transplant Unit, Auckland Hospital.
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