Metabolic Syndrome
- type 2 diabetes
- liver disease (NAFLD and NASH)
- hyperlipidemia
The Problem. Metabolic Syndrome is a a complex and progressive disorder that has reached epidemic proportions. Type 2 diabetes is characterized by the inability to regulate and use glucose, and it is associated with increases in heart disease, liver disease, stroke, kidney disease, and blindness. The US spent $176 billion, including over $50 billion to treat type 2 diabetes, in 2012. Fatty liver disease is an underappreciated but a serious unmet medical need that costs about $3 billion to treat in the US. Hyperlipidemia is also a serious problem that is associated with heart disease and other disorders, and the US spends about $19 billion on medication for lowering cholesterol alone.
The Solution. We are developing a drug that treats all three of these conditions. This drug specifically
interacts with a single retinoic acid receptor. It normalizes blood sugar and supports the survival of the cells that produce insulin (these cells often die as type 2 diabetes progresses)
in animal models. It also reverses fatty liver disease, a disorder that has no current medical therapy. Finally, it reduces the levels of circulating cholesterol and other
lipids. Our preliminary data indicate that the drug we are using has excellent pharmacological properties and no unexpected toxicities.
The Next Milestones. Our next goal is to do more detailed pharmacological and toxicological studies to support an IND (Investigative New Drug) application to the FDA. If these studies go as expected, we will move to phase one and then phase 2 trails. Because there is no drug to treat fatty liver disease, this is the first indication that we will pursue, but trials for treatment of type 2 diabetes and hyperlipidemia are also warranted. There are existing medical therapies for both of these conditions, but because the drug we are developing is a first-in-class for these indications, it may be especially valuable and may be synergistic with other medications in combination therapy.
The Investment Opportunity. Sveikatal, Inc. seeks partners and investors to provide financing and expertise to reach our near-term and
long-term goals. We estimate that, because there is no current therapy, sales of this drug for fatty liver disease should reach $2 billion within 5 years. Because of the large market
for type 2 diabetes and potential synergism with existing therapies, this indication should also command $2 billion in
sales, though penetration of the market may be slowed because there are so many drugs in use for treatment of this disorder.