Inventiva and Hepalys Pharma have commenced their clinical development program in Japan, marking a significant milestone in their partnership to bring innovative MASH treatment to Asian markets. The program launched with the first Japanese participant receiving a dose in a Phase 1 clinical trial of lanifibranor, a novel pan-PPAR agonist.
Trial Design and Objectives
The single-center study will evaluate 32 participants, randomly assigned to four cohorts, who will receive daily doses of lanifibranor over a 14-day period. The trial aims to assess the drug's safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in Japanese subjects.
This initial study represents a crucial step in the development pathway established under the 2023 exclusive licensing agreement between Inventiva and Hepalys. Under this partnership, Hepalys holds responsibility for conducting and funding all necessary trials in Japan and South Korea required for new drug applications in these territories.
Strategic Market Importance
The Japanese market presents a significant opportunity, with up to 2.7% of the population affected by Metabolic Dysfunction-Associated Steatohepatitis (MASH). Successful completion of this Phase 1 trial could pave the way for a pivotal Phase 3 trial in Japanese MASH patients, contingent upon results from Inventiva's ongoing global NATiV3 Phase 3 trial.
"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," stated Frederic Cren, CEO and cofounder of Inventiva.
Innovative Treatment Mechanism
Lanifibranor distinguishes itself as the only pan-PPAR agonist in clinical development for MASH treatment. The drug's unique mechanism involves moderate and balanced activation of all three PPAR isoforms (α, δ, and γ), potentially contributing to its favorable tolerability profile observed in clinical trials to date.
The FDA has already recognized lanifibranor's potential by granting it both Breakthrough Therapy and Fast Track designations for MASH treatment, underlining the drug's importance in addressing this significant unmet medical need.
Dr. BT Slingsby, Representative Director of Hepalys Pharma, expressed optimism about the program: "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."
