Inventiva and Hepalys Pharma Kickstart Lanifibranor's Japanese Journey with Phase 1 Trial

In a significant step towards expanding its global reach, Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company, and Hepalys Pharma, Inc., a venture-backed biopharmaceutical company focused on liver disease, have announced the initiation of the clinical development program of lanifibranor in Japan. The dosing of the first participant in the Phase 1 trial marks a crucial milestone in the partnership between the two companies, aiming to develop and commercialize lanifibranor in Japan and South Korea.

The Phase 1 trial, conducted pursuant to the terms of the exclusive licensing agreement between Inventiva and Hepalys, is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of lanifibranor in Japanese patients and healthy volunteers. The single-center study will enroll 32 subjects, who will be randomly assigned to four cohorts and receive lanifibranor once daily for 14 days. 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 Japanese market for MASH presents a significant opportunity for Inventiva and Hepalys Pharma, Inc. With up to 2.7% of the Japanese population suffering from MASH, the market size is comparable to other regions, such as the United States, where up to 30 million people are affected by NASH, a related liver disease. The partnership with Hepalys Pharma, Inc. enables Inventiva to leverage Hepalys' local expertise and resources to advance the clinical development of lanifibranor in these territories, potentially accelerating the drug's time to market and diversifying revenue streams.

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, MD, PhD, MPH, 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."

In conclusion, the initiation of the Phase 1 trial in Japan for lanifibranor is a significant step in Inventiva's global development strategy, expanding the drug's reach to a new major market. The partnership with Hepalys Pharma, Inc. presents opportunities for market penetration and revenue growth, as the companies aim to enter the Japanese market with lanifibranor, if approved. Positive results from this trial could support the initiation of a pivotal Phase 3 trial in patients in Japan with MASH, further strengthening the companies' position in the Japanese market.