The Problem

Diabetes and related metabolic diseases are significant growing health risks in the developed and developing world. In the United States, treatment of diabetes and its complications costs more than any other disease and is responsible for one third of all Medicare spending. There are about 25 million people with type 2 diabetes in the US today, a number that is expect to rise to almost 30 million by 2035.

In human terms the cost is staggering: each day in the United States almost 4,000 people are diagnosed with the disease, 200 will undergo diabetes-related amputations, 136 will enter end-stage kidney disease treatment and 1,795 will develop severe retinopathy that can lead to vision loss and blindness.

While these numbers suggest a health issue of epidemic scale, the situation in the developing world is significantly worse. China and India will each add 50 million new patients with type 2 diabetes over the next 20 years. The cost of caring for these additional patients will strain health care budgets all over the developing world.

 

The Solution

Naia Metabolic is developing a new drug, NC 102, for type 2 diabetes and a new drug (NC 101) to treat one of the more serious complications associated with obesity and type 2 diabetes, Non-Alcoholic Steatohepatitis or NASH.

NC 102 is a combination of two generic drugs currently in use, each of which has extensive safety records. The combination of the two has shown unexpected and positive results in human clinical trials. By acting to speed up the activity of mitochondria, NC 102 acts to sensitize the body’s reaction to insulin, and allows the body to consume both glucose and fatty acids faster. We believe that this is the first drug to be tested in humans that works in this way. Because of the way it works, it will very likely work well with other diabetes drugs and as a result have a larger impact on blood sugars than those drugs alone.

NC 101 is the key component in the combination and is a repurposed medicine which has now only limited current use in the USA and Canada and is not marketed elsewhere. It has a history of safe use for approximately 30 years. In clinical studies, NC 101 significantly lowered the enzyme Alanine Aminotransferase (ALT) in patients with diabetes. ALT levels rise as a result of liver damage and liver damage is associated with another metabolic disease, NASH. Patients with type 2 diabetes often have NASH or its precursor, Non-Alcoholic Fatty-Liver Disease or NAFLD. NAFLD is the most common liver disorder in developed countries and is believed to affect 80% of the obese population. As the disease progresses in a subset of patients, livers become damaged, characterized by inflammation, cellular ballooning and fibrosis. This condition is NASH.

There are no approved drugs to treat NAFLD and NASH, and while several are now in development, there is a consensus that both will require a cocktail of drugs which work by different mechanisms. NC 101 which works by increasing insulin sensitivity in the liver, also increases fatty acid utilization in muscle tissue and glucose utilization in the liver. The combined effects markedly reduce the amount of fat in the liver, an effect now confirmed in two animal models of the disease.

Both NC 101 and NC 102 will enter clinical studies in late 2016 and are expected to be on the market by 2022.