In a recent news release, biopharmaceutical company Aligos Therapeutics, Inc. (“Aligos”) shared that the first healthy volunteers were dosed in a Phase 1 clinical trial evaluating ALG-055009 for nonalcoholic steatohepatitis. Within the ALG-055009-301 trial, researchers hope to evaluate the safety, tolerability, pharmacokinetic profile, and pharmacodynamic profile of ALG-055009. Additionally, the trial will evaluate singular ALG-055009 doses versus multiple doses. 152 patients are expected to enroll in the full trial.
ALG-055009
ALG-055009 is a thyroid hormone receptor β (THR-β) agonist. According to Aligos:
Although no drugs have been approved for the treatment of NASH, thyroid hormone receptor β (THR-β) agonists have demonstrated potential to reduce liver fat, restore liver functions, and possibly reverse fibrosis.
So far, Aligos has evaluated ALG-055009 in mouse models. After 4 weeks of treatment:
The minimum efficacious dose of 0.15 mg/kg/dose…resulted in 17% and 34% reduction in total and LDL cholesterol, respectively. This study demonstrated that ALG-055009 was highly efficacious in the DIO mouse model, and its pharmacological effect was primarily driven by plasma and liver Cmin.
Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a disease in which fat accumulates in the liver, causing inflammation and liver damage. Unlike some other conditions, NASH occurs in people who do not drink (or who do not drink a lot). Altogether, doctors are not sure exactly what causes NASH: potentially a combination of environmental and genetic factors? However, there are risk factors, which include being obese, having type 2 diabetes (T2D), having metabolic syndrome, or having high cholesterol.
Some patients with NASH may not experience symptoms – or their conditions may not progress. However, in other cases, NASH causes scar tissue to form on the liver, reducing its function. An estimated 25% of Americans have NASH. Symptoms include, but are not limited to:
- Easy bruising and bleeding
- Jaundice (yellowing of the skin, eyes, and mucous membranes)
- Fatigue and/or general malaise and weakness
- Pruritus (intense itchiness)
- Unintended weight loss
- Spider-like blood vessels
- Fluid accumulation in the abdomen
- Note: This may occur alongside abdominal pain.
- Appetite loss
- Nausea and vomiting
- Swelling of the lower extremities
- Mental confusion
