According to a story from Markets Insider, the biotechnology company Innovate Biopharmaceuticals, Inc., recently announced encouraging proof-of-concept data for its lead medical product larazotide acetate. This experimental drug appears to have a positive effect on patients with nonalcoholic steatohepatitis, a rare liver disease that currently has no FDA approved therapies. The company hopes to begin clinical trials with larazotide in 2019.
About Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a type of liver disease in which fat is deposited in the liver independent of excessive alcohol consumption. This disease can progress rapidly. Risk factors include metabolic syndrome and insulin resistance. There also appears to be some genetic component to the disease as well. This condition also increases the risk of other health problems and liver cancer. Men also seem to be at greater risk, getting the disease as almost twice the rate that women do. Symptoms of nonalcoholic steatohepatitis include jaundice, malaise, fatigue, and abdominal pain or discomfort. Without treatment, the liver can become scarred and the patient may need a liver transplant. However, the condition can also be managed with proper diet, the use of certain medications, and exercise. To learn more about nonalcoholic steatohepatitis, click here.
Larazotide and Nonalcoholic Steatohepatitis
Larazotide primarily functions as a tight junction regulator, which serves to return leaky junctions to their normal levels of permeability. One of the disease characteristics that often appears with nonalcoholic steatohepatitis is the “leaky gut” phenomenon. The effects of this disease include disturbances to the lining of the gut, which makes it more likely that material from the intestine could be passed to the liver. This could include potentially toxic substances that could contribute to liver damage and cause inflammation.
Research
In the proof-of-concept study, scientists utilized a mouse model of nonalcoholic steatohepatitis. When the affected mice were administered larazotide, the permeability of their gut was brought back to normal levels by a substantial margin. Normally, this leaky gut tends to become worse as the disease progresses, so a drug that could prevent could restore normal permeability could make it much easier for patients to recover from nonalcoholic steatohepatitis.
The company believes that larazotide would best be used as part of a combination treatment with other medications. There are a number of experimental therapies that are being tested for nonalcoholic steatohepatitis and it may be possible that one of them could be synergistic with larazotide.
