According to a recent article published in The Online Trading Mentor, Inventiva S.A. (Inventiva) has recently opened enrollment for its Phase 3 trial of Lanifibranor, an investigational treatment for nonalcoholic steatohepatitis (NASH). This next step forward is exciting for researchers and patients alike, especially as NASH currently faces an unmet medical need.
About NASH
First, it’s important to understand what NASH is. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. This leads to inflammation and scarring which may go on to impact liver function. Currently, this condition affects up to 25% of Americans but still faces an unmet medical need. While research is being conducted to fill this gap, the treatment options that exist now are lowering cholesterol, losing weight, controlling diabetes, avoiding alcohol, and maintaining a healthy diet and exercise regimen.
Symptoms of NASH include:
- Jaundice
- Itching
- Weakness
- Nausea
- Vomiting
- Fatigue
- Swelling in the legs and abdomen
- Mental confusion
- Loss of appetite
- Abdominal pain
- Spider-like blood vessels
About the Phase 3 Trial
Not only are drug developers excited by the potential Lanifibranor holds to fill a gap regarding treatments for NASH, but they’re motivated by the positive results of the previous Phase 2b NATIVE trial. This study placed the investigational drug at the lead of the pack for NASH treatments currently in development. It demonstrated that Lanifibranor met fibrosis improvement and NASH resolution endpoints. It may also offer cardiovascular benefits, but further investigation is required to know this for sure.
Now, it is time to move to the Phase 3 NATIVE3 trial, which expects to enroll its first participants this quarter. 900 NASH patients with moderate to advanced fibrosis are expected to join the study. It will be randomized and double-blind with the intention of evaluating 800 mg QD and 1200 mg QD of Lanifibranor vs. placebo.
Two regulatory agencies, the FDA and EMA, have already given this trial their approval. Additionally, the initial endpoints have been established as fibrosis improvement and NASH resolution after 72 weeks.
If all continues to go well, Lanifibranor could be on track to receive accelerated approval in the United States and conditional approval in the European Union.
