Inventiva Additional analysis following SUSAR in NATiV3 trial in MASH
Following Inventiva's announcement of a SUSAR in 1 patient suspected of autoimmune hepatitis (AIH) leading to the voluntary pause in recruitment for the phase 3 (NATiV3) trial with lanifibranor in MASH, we wanted to highlight a few important points. First, the DMC recommended protocol modifications (additional monitoring and future exclusion of AIH/thyroid disease patients), but for the trial to continue - this is a good sign as the DMC have visibility on which arm the patient was in, and they may have been on placebo. Existing patients continue to be dosed, which suggests there is limited risk and more frequent monitoring appears to be sufficient. Finally, while there could be some impact on market opportunity with approx. 10-15% of patients excluded, MASH is a big enough pie. We adjust our model arriving at a PT of € 10 (from € 13). We continue to believe in lanifibranor's commercial potential and reiterate our 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.
We are a financial services provider for several types of professional clients, each with distinct needs.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.