Inventiva announces positive topline results from the investigator-initiated Phase II clinical trial evaluating lanifibranor in patients with T2D and NAFLD

Paris-based biopharmaceutical company, Inventiva, has announced positive topline results from its investigator-initiated Phase II clinical trial evaluating lanifibranor in patients with Type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD).

The trial showed that the drug met its primary endpoint by significantly reducing liver fat content by week 24. The drug also showed statistically significant benefits in secondary endpoints including liver enzymes and metabolic parameters, reinforcing its therapeutic potential in T2D and NAFLD.

This is significant news for Inventiva and for those living with T2D and NAFLD, as currently there are no treatments approved to target both conditions simultaneously. This trial shows promise in addressing a major unmet medical need.

The trial enrolled 100 patients across 10 sites in France, Germany and Belgium, and was conducted as part of the framework of the Company’s ongoing collaboration with Professor Vlad Ratziu of Sorbonne University and the Pitié-Salpêtrière Hospital in Paris.

The multi-center, randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and efficacy of lanifibranor in patients with well-controlled T2D and biopsy-confirmed NAFLD.

Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist. It selectively targets PPAR alpha, PPAR delta and PPAR gamma, which are all nuclear receptors involved in metabolism, inflammation and fibrosis.

The drug has demonstrated potential in treating conditions such as T2D, NAFLD, systemic sclerosis and Maroteaux-Lamy syndrome. It has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of NAFLD with liver fibrosis.

Dr. Frederic Cren, CEO and co-founder of Inventiva, said: “The impressive results of this trial are particularly encouraging considering the high unmet medical need for patients suffering from both T2D and NAFLD, a disease that is rapidly becoming a leading cause of liver transplants worldwide and for which no approved treatment currently exists.”

Inventiva plans to use the positive data from this Phase II trial to advance lanifibranor into a Phase III clinical trial for NAFLD with liver fibrosis. The company is confident that these results will propel lanifibranor towards regulatory approval and eventual commercialization.

Dr. Marie-Paule Richard, Chief Medical Officer of Inventiva, said: “We are very excited by these excellent results demonstrating the beneficial effect of lanifibranor on both liver fat and key metabolic markers in patients with T2D and NAFLD. We now look forward to advancing the clinical development of lanifibranor further for the benefit of patients who are in dire need of effective therapies.”

With its Fast Track designation, lanifibranor could be eligible for expedited review and regulatory support from the FDA, potentially bringing it to market sooner and providing a much-needed treatment option for those with T2D and NAFLD.

Inventiva’s positive topline results from its Phase II clinical trial evaluating lanifibranor in patients with T2D and NAFLD is a significant step forward in addressing a major unmet medical need. The drug showed promise in reducing liver fat content and improving metabolic parameters, reinforcing its therapeutic potential for these conditions.

The company plans to use these positive results to advance the drug into a Phase III clinical trial and ultimately towards regulatory approval and commercialization. With its Fast Track designation, lanifibranor could be fast-tracked through the regulatory process, potentially becoming a much-needed treatment option for those living with T2D and NAFLD.