Inventiva FIRST LOOK: Hepalys starts Ph1 with lani for Japan/South Korea
Inventiva makes progress in its exclusive licensing agreement with Hepalys that was announced in September 2023 to develop and commercialize lanifibranor for the treatment of MASH patients in Japan and South Korea. The first participant has now been dosed in a Ph1 study to assess the safety, tolerability and PK/PD profile of the drug. Upon completion of this study and following Inventiva's EU/US pivotal NATiV3 readout, Inventiva and Hepalys could advance into a pivotal study for the region. We see today's news as a step in the right direction, and reiterate our € 7 TP and Buy rating.Inventiva is a clinical stage biotechnology research company delivering therapies in the areas of oncology, fibrosis and rare diseases. The most advanced clinical programs (IVA337 for systemic sclerosis in Non-Alcoholic Steato-Hepatitis and IVA336 for Maroteaux-Lamy syndrome-MPS VI) have demonstrated efficacy in relevant in vivo and in vitro models as well as safety in phase I and phase II clinical trials. Using its in-house drug discovery platform, which covers target validation, screening, chemistry, ADME and pharmacology, Co. is developing an internal oncology and fibrosis discovery pipeline with approaches centered on transcription factors, epigenetics targets and nuclear receptors.
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