Tasly/Axeon US Drug Development Projects Available for Co-development or Investments
This product is developed for the prevention and treatment of Nonalcoholic fatty liver disease (NAFLD).
Nonalcoholic fatty liver disease (NAFLD) is considered to be the most common liver disorder in the Western world. It is present in the general population of the US in about 20 to 40% and there is an estimate of about 96 million people with NAFLD (most of them remain undiagnosed) in the US.
The more severe form of NAFLD is non-alcoholic steatohepatitis (NASH), liver inflammation. Furthermore, Non-alcoholic steatohepatitis is one of the leading causes of cirrhosis in adults in the United States. Up to 25% of adults with non-alcoholic steatohepatitis may progress to cirrhosis.
No FDA approved effective treatment of NAFLD/NASH till now.
Nafliva is the combination of several natural ingredients in the proprietary ratio: Silymarin extracts from Milk Thistle and Pu-erh tea extract (the bacteria composition and process applied to Pu-erh tea fermentation is uniquely designed after extensive research).
Pre-clinical studies to investigate whether Nafliva can protect mice from obesity-related disease, especially NAFLA/HASH was conducted at Chicago University.
Nafliva was given to mice fed with a high-fat, high cholesterol diet (60% fat kcal) to determine if Nafliva can reduce obesity-induced liver tissue inflammation and metabolic disorder especially, Nonalcoholic fatty liver disease (NAFLD) conditions.
The study result showed that after 10 weeks of treatment, Nafliva can attenuate obesity-induced liver tissue inflammation and can protect mice from obesity-associated metabolic disorder (Study report is available upon request).
In about 10 volunteers who were clinically diagnosed to have moderate to severe NAFLD/NASH, after 6-10 weeks of treatment, their NAFLD/NASH conditions were reported to have been mostly cleared (patient self-reported data).
The animal study result is very promising and will continue in 2019 to explore its mechanism of action.
A pre-IND meeting with the US FDA was held in 2017. The feedback from the FDA was very positive. The FDA encourages the sponsor to modify the formulation and should be ready for clinical trial due to the ingredients are all GRASE material.
Biopsy in about 25 subjects out of the few hundreds of total subjects will be sufficient to meet FDA requirement for approval.