On March 29, 2022, globally diversified chemical company LG Chem announced via press release that its Investigational New Drug (IND) application was approved by the U.S. Food and Drug Administration (FDA). In short, this means that the company is now able to launch a Phase 1 clinical trial. During these trials, LG Chem will evaluate the safety, efficacy, tolerability, pharmacokinetic profile, and pharmacodynamic profile of LG203003. This orally-administered therapy is designed for patients with nonalcoholic steatohepatitis (NASH). Altogether, 88 participants will enroll in the trial. Some will be adults with NASH, while others will be healthy controls.
LG203003 works by inhibiting DGAT-2 and preventing it from activating. Through this, the drug aims to reduce fat accumulation in the liver, therefore reducing inflammation, scarring, and damage. So far, the treatment has shown promise in preclinical studies. Within these studies, the drug not only helped to reduce scarring and swelling, but also effectively lowered triglycerides.
This is not LG Chem’s first attempt to create a drug for NASH. In fact, the company’s other drug candidate, LG303174, has already been evaluated in Phase 1 trials. The company hopes to begin Phase 2 trials for this particular therapy by the end of 2022.
About Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a disease found in those who drink very little or do not drink at all. It mimics the liver disease often found in long-term heavy drinks, and is characterized by fat accumulation in the liver. As this fat accumulates, it can cause inflammation, scarring, damage, and even a loss of liver function. Doctors are not entirely sure exactly what causes nonalcoholic steatohepatitis, although some believe it could be a mix of hereditary and environmental factors. However, nonalcoholic steatohepatitis is more likely to occur in those who are overweight, who have high cholesterol or metabolic syndrome, or who have type 2 diabetes. Symptoms associated with nonalcoholic steatohepatitis include:
- Nausea and vomiting
- Unintended weight loss
- Jaundice (yellowing of the skin and eyes)
- Pruritus (intense itching)
- Appetite loss
- Fatigue and general weakness
- Swelling of the legs and abdomen
- Abdominal pain
- Confusion
- Spider-like blood vessels
- Red palms
- An enlarged spleen
- Easy bruising and bleeding
