NASH is a liver disease characterized by fat accumulation, inflammation, fibrosis, and hepatocellular damage of the liver, which can lead to cirrhosis and liver cancer if left untreated. Approximately four million NASH patients live in Japan with rates of prevalence on the rise in recent years. Today, no drugs are approved in Japan for NASH, and many candidates in clinical development worldwide have yet to begin development.

Lanifibranor is an orally available small molecule that has demonstrated to reduce fibrosis and resolve NASH in addition to improve several metabolic markers in an international phase 2B trial in patients with NASH. A global pivotal phase 3 trial for lanifibranor is underway and Hepalys will galvanize the clinical development of lanifibranor in Japan and Korea in hopes of helping patients with NASH who otherwise would progress to cirrhosis and liver cancer.

Inventiva was looking for a partner to license out the rights to its lead asset, lanifibranor, in Japan and South Korea with the aim of accelerating the development and commercialization of lanifibranor in Asian markets. We had the opportunity to discuss with various potential local partners, but saw the greatest potential in out-licensing to a new company (Hepalys Pharma) backed by Catalys Pacific and other well-known institutions. We chose this option over out-licensing to a pharmaceutical company because the process of establishing a new company can maximize the value of lanifibranor by allowing us to assemble the most experienced team for the clinical development of the asset in Japan and South Korea. Furthermore, Hepalys’ internal resources will be devoted entirely to lanifibranor’s development program. Through this collaboration, we are confident that lanifibranor will potentially become the best-in-class solution for patients with liver disease in Japan and South Korea.

Yes, of course, strategic regional partnering will certainly benefit other companies as well. We at Inventiva have a deep expertise in developing our lead asset. However, partnering with Heplays allowed us to put our focus on our main markets, the USA and Europe, while ensuring that lanifibranor is also being developed in two of the most important Asian markets. We are participating in Hepaly’s commercial success through licensing income, royalties and shared ownership in the company. A true win-win collaboration.