Planning for Phase 3 for Study of Treatment for NASH Has Begun

 

Galectin Therapeutics has recently started to plan the third phase of its clinical trial of belapectin, which treats nonalcoholic steatohepatitis (NASH). They are making refinements based on a conversation with the FDA and plan to conduct this phase of the study in order to confirm the dosage. The target population of this drug is those who are at risk of developing esophageal varices and Phase 2 of this trial has already shown positive results within this population. Galectin hopes that the rest of their trial will continue to have positive results as well.

About Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic steatohepatitis (NASH) is a disease that is characterized by a buildup of fat in the liver that causes inflammation and liver damage. This disease affects those who drink very little or not at all, but mimics the liver disease of heavy drinkers. The liver damage has the potential to cause enough scar tissue that it prevents the liver from functioning. It affects up to one quarter of the people in the United States.

There is a debate about the cause of NASH. Some healthcare professionals believe that it is inherited, while others think it is triggered by environmental factors. The exact cause is unknown, but there are risk factors that are known to increase the chance of developing NASH. These include obesity, type 2 diabetes, high cholesterol, and metabolic syndrome.

NASH is not always symptomatic, and it does not always progress. Symptoms can vary from person to person. Some of these symptoms include weakness, fatigue, weight loss, nausea, vomiting, loss of appetite, jaundice, itching, mental confusion, abdominal pain, swelling in the legs or abdomen, and spider-like blood vessels.

The first step in diagnosing this disease is a blood test. Other tests will follow in order to rule out other conditions. An ultrasound confirms the diagnosis. After a doctor confirms that it is NASH, treatment options include weight loss, lowering one’s cholesterol, avoiding alcohol, controlling one’s diabetes, a healthy diet, and exercise.

About Belapectin

Belapectin, a complex carbohydrate drug, targets galectin-3. This protein plays an important role in fatty liver disease and fibrosis. Belapectin binds to galectin-3 and stops its function. It is the first drug in a large, randomized study to demonstrate clinically meaningful improvements in portal hypertension or liver biopsies.

About the Study

Galectin Therapeutics recently presented its plans for the Adaptively Designed Phase 3 of its clinical trial of belapectin in a meeting with shareholders. These plans were created based on feedback from the FDA. This phase is meant to confirm the dosage along with the results from previous phases. It will last 12-18 months and enroll patients who do not have esophageal varices. Galectin will conduct a Hepatic Impairment study at the same time in order to include people with more advanced cirrhosis. Enrollment will be based on the presence or absence of varices, spleen size, platelet count, and the evidence of collaterals. Enrollment should begin near the end of the first quarter of 2020.

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