According to a story from dernieresactus.fr, the biopharmaceutical company Inventiva has recently announced plans for its upcoming phase III clinical trial. This trial will investigate its lead candidate lanifibranor as a possible treatment for nonalcoholic steatohepatitis (NASH). Inventiva is focused on developing orally active small molecule therapies for mucopolysaccharidoses, nonalcoholic steatohepatitis, and other disease states with high unmet need.
About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH) is a type of liver disease in which fat is deposited in the liver independent of excessive alcohol consumption. This disease can progress rapidly. Risk factors include metabolic syndrome and insulin resistance. There also appears to be some genetic component to the disease as well. This condition also increases the risk of other health problems and liver cancer. Men also seem to be at greater risk, getting the disease as almost twice the rate that women do. Symptoms of nonalcoholic steatohepatitis include jaundice, malaise, fatigue, and abdominal pain or discomfort. Without treatment, the liver can become scarred and the patient may need a liver transplant. However, the condition can also be managed with proper diet, the use of certain medications, and exercise. To learn more about nonalcoholic steatohepatitis, click here.
Trial Design
The plans and design for this trial have already been shared with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company plans to seek Accelerated Approval in the US and conditional approval in Europe based on a histology analysis including around 900 patients which will last 72 weeks. In addition, the company will use a composite endpoint in the phase III trial which will include both improvement in fibrosis (scarring) and NASH resolution.
The goal with this endpoint is that it should be able to predict a major improvement in prognosis. This endpoint was also used in the earlier phase IIb trial. Other endpoints will include insulin resistance, other markers of fibrosis, and effects on lipids. The regulatory agencies have also agreed that the 72 week period is sufficient for the establishment of long-term use data.
Patients will receive either a placebo, and 800 mg dose, or a 1200 mg dose of lanifibranor daily during the trial. An estimated 2,000 patients in total are expected to be involved.
