Inventiva And Hepalys Initiate Phase 1 Trial In Japan For Lanifibranor As A Treatment For MASH

The clinical-stage biopharmaceutical company Inventiva started a Phase 1 clinical study in Japan in collaboration with partner Hepalys Pharma, a company incorporated in Japan and founded by Catalys Pacific, to test how lanifibranor functions as a daily oral therapy for treating metabolic dysfunction-associated steatohepatitis (MASH). The clinical trial is a single-centre study to evaluate the safety and tolerability of lanifibranor along with pharmacokinetic and pharmacodynamic measurements in 32 patients spread across four treatment groups during a 14-day dosage period. 

Frederic Cren, CEO and co-founder 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.”

The trial is conducted on the basis of an exclusive licensing agreement between the two companies in 2023. According to the agreement, Hepalys has taken responsibility for developing and commercializing lanifibranor for the Japanese and South Korean markets. The successful study outcomes might open doors to vital Phase 3 trial operations within Japan with parallel activities ongoing in the global Phase 3 NATiV3 study managed by Inventiva. The approval of lanifibranor would solve an important clinical gap in Japan because up to 2.7% of its population suffers from MASH.

“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,” commented, BT Slingsby, MD, PhD, MPH, Representative Director of Hepalys Pharma, Inc.