The FDA has recently approved of Viking Therapeutics’ Investigational New Drug (IND) application, which allows patients to enroll in their clinical trials. In order to qualify for these trials, people must have certain comorbid conditions or be receiving lipid-lowing medications. The drug that will be tested is VK2809, which is meant to treat people with non-alcoholic steatohepatitis (NASH). The trials are looking to evaluate the safety and efficacy of the drug, and they follow prior studies that have had promising results. These six previous clinical studies, which included more than 260 participants, showed no adverse effects of the drug. Viking Therapeutics has spoken about the results of previous trials and their excitement for upcoming studies.
About Non-Alcoholic Steatohepatitis (NASH)
Non-alcoholic steatohepatitis (NASH) is a disease that mimics the liver disease of long-term heavy drinkers, despite the fact that those who have NASH are often non-drinkers or drink very little. Fat buildup in the liver causes inflammation and damage, which can end up creating scar tissue on the liver that prevents function. While it does not always worsen or even show symptoms, it is important to monitor and manage to avoid this loss of function of the liver. The cause of this disease is debated, as it could be an inherited disease or it could be triggered by other factors. While the exact cause is unknown, there are risk factors that doctors advise people avoid. These triggers include obesity, type 2 diabetes, high cholesterol, and metabolic syndrome.
25% of the people in the United States are affected by NASH and can experience the symptoms, which include weakness, fatigue, weight and appetite loss, jaundice, nausea, itching, mental confusion, swelling of the legs and abdomen, abdominal pain, and spider-like blood vessels. Once these symptoms are noticed, doctors test blood samples in order to look at the liver enzyme count. Various tests rule out other conditions, and finally a NASH diagnosis is confirmed through an ultrasound. There is no cure for NASH, and treatment often means lowering the risk factors. Avoiding alcohol, lowering cholesterol, eating healthy, exercising, losing weight, and controlling diabetes are all helpful in treating NASH and its symptoms.
Clinical Trials and VK2809
VK2809 is a drug taken orally, which is a selective agonist of the thyroid beta receptor that works specifically with the liver tissue. It also deals with the beta receptor subtype, meaning that it has the potential to treat multiple lipid disorders. This selectivity of the thyroid beta receptor is meant to help cholesterol and lipoprotein levels. The six clinical studies that have already been conducted on this drug were meant to test the safety and efficacy. They found no adverse affects of the drug and found that the tolerability of the drug was promising. Chronic toxicity was also evaluated for twelve months. The trials studied various dosages as well, along with the drugs effects on primates and rodents. The newest trial will involve people with biopsy confirmed NASH and fibrosis, at about 340 people total. It is a random, double-blind, placebo-controlled study that will evaluate the safety and tolerability of VK2809.
About Viking Therapeutics
Viking Therapeutics is a biopharmaceutical company that specializes in metabolic and endocrine disorders. They develop oral, novel drugs meant to improve the lives of patients. They hold the exclusive rights to five therapeutic programs, which are meant to treat conditions like X-linked adrenoleukodystrophy (X-ALD) and non-alcoholic fatty liver disease (NAFLD).
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