Inventiva and Hepalys Pharma have initiated the clinical development program of lanifibranor in Japan with the first Japanese participant dosed in a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of lanifibranor.

As part of the single-center study, 32 subjects will be separated randomly into four cohorts and will receive lanifibranor once daily for 14 days.

The trial is conducted pursuant to the terms of the exclusive licensing agreement entered into in 2023 between Inventiva and Hepalys to develop and commercialize lanifibranor in Japan and South Korea. Under the terms of the agreement, Hepalys is responsible for conducting and financing all trials in Japan and South Korea needed to file for a new drug application in these territories. Positive results from this trial could support the initiation of a pivotal Phase 3 trial in patients in Japan with MASH, once the results of NATiV3, the pivotal Phase 3 trial currently conducted by Inventiva, are available. 

The trial represents a key first step in Inventiva’s and Hepalys’s partnership, as the companies aim to enter the Japanese market with lanifibranor, if approved, where up to 2.7 percent of the Japanese population suffer from MASH.

Frederic Cren, CEO and cofounder of Inventiva, stated, “The inclusion of the first participant in the Phase 1 study in Japan testifies to the strength of our partnership with Hepalys as we progress with the development of lanifibranor with our goal to make it accessible to a significant number of MASH patients. The partnership with Hepalys enables us to start development in a key market such as Japan, where our partner's local expertise is key to the program's success.”     

BT Slingsby, Representative Director of Hepalys Pharma, Inc., stated, “It has been an exciting build-up of the clinical program for lanifibranor, and we are thrilled about the first participant dosed in this Phase 1 clinical trial, which is a key first step in the progression of our clinical development planned for lanifibranor. If successful, it will propel our work in potentially launching this drug candidate in Japan, as a potentially life-saving treatment for patients with MASH. We look forward to the ongoing dosing of patients and to results from this trial.”