In November 2020, Viking Therapeutics (“Viking”) shared insight into their metabolic disease program. According to Greg Zante, the Senior VP (SVP) of Finance for Viking, the company’s treatment VK2809, licensed from Ligand Therapeutics, shows significant benefits for patients with nonalcoholic steatohepatitis (NASH). In fact, data shared at the Stifel 2020 Virtual Healthcare Conference suggested that the treatment could reduce liver fat and LDL cholesterol levels by up to 78%.
Overall, VK2809 is an orally administered thyroid hormone mimetic. It is taken once daily. Recently, Viking evaluated VK2809 within the Phase 2b Voyage clinical trial. Trial participants began the trial with 8%+ liver fat readings, which is considered high. Additionally, participants had high levels of LDL cholesterol and triglycerides. Next, patients received VK2809 for a 12-week (3 month) period. The therapy is localized to the liver, allowing a more effective and targeted treatment approach. Within both 4 and 24 hours, testing showed high concentrations of VK2809 in the liver. However, there was minimal concentration in other bodily tissues. As a result, it is clear that the drug does remain localized to the liver.
VK2809 works by activating thyroid beta receptors. Once activated, these beta receptors play a role in reducing fibrosis and liver fat, lowering cholesterol levels, raising the heart rate, and improving metabolic health and function. Considering the results of this trial, it seems as though the drug is capable of reaching these goals. Following the 12-week period, VK2809 reduced liver fat by 72-78% in trial participants. It also reduced LDL cholesterol by up to 28.3mg/dL. Even if patients did not reach the 78% fat reduction, a majority of patients (88%) experienced at least 30% fat reduction.
Alongside VK2809, another thyroid receptor beta agonist exists within Viking’s metabolic and rare disease program: VK0214. This treatment is designed for patients with adrenoleukodystrophy (X-ALD). X-ALD causes damage to the myelin sheath, or the protective covering of nerve cells. As a result, patients experience hyperactivity, seizures, muscle spasms, and vision impairment. In September 2020, Viking initiated a Phase 1 study to evaluate VK0214 for X-ALD. Another Phase 1b trial will begin in 2021.
Nonalcoholic Steatohepatitis (NASH)
Up to 25% of Americans have nonalcoholic steatohepatitis (NASH), a liver disease in those who do not drink or drink very little. People with NASH experience fat accumulation in the liver. This prompts liver inflammation, damage, and sometimes fibrosis (scarring). In patients with fibrosis, liver function declines. Typically, NASH is more likely to develop in those who have diabetes, have high cholesterol, or are overweight. Symptoms include:
- Nausea and vomiting
- Unintended weight loss
- Muscle weakness
- Abdominal pain and swelling
- Appetite loss
- Pruritis (extreme itching)
- Jaundice (yellowing of the skin and eyes)
- Confusion or mental fogginess