Inventiva (IVA) Morgan Stanley 24th Annual Global Healthcare Conference summary

Current status and clinical focus

• Approaching a pivotal phase III readout for lanifibranor, expected in Q4, targeting MASH by addressing both liver scarring and metabolic dysfunction.

• Lanifibranor demonstrated an 18% reduction in fibrosis in phase II, aiming to replicate or improve this in phase III.

• The drug's dual mechanism targets both intrahepatic and extrahepatic disease drivers, differentiating it from existing therapies.

• Market for MASH therapies is expanding, with lanifibranor positioned to address unmet needs not covered by current treatments.

• Combination therapies, especially with GLP-1s, are anticipated as the future standard, with lanifibranor designed for compatibility.

Clinical differentiation and efficacy

• Lanifibranor's pan-PPAR mechanism targets multiple metabolic pathways, potentially offering superior disease control.

• Existing approved therapies address either liver or metabolic aspects, but not both; lanifibranor aims to fill this gap.

• Phase IIb data showed efficacy within six months, which is faster than GLP-1s that require longer treatment for effect.

• Weight gain observed is attributed to fluid retention, a manageable side effect familiar to physicians using similar drugs.

• Safety profile is expected to be manageable, with fluid retention mitigated by diuretics or SGLT2 inhibitors.

Commercial landscape and future plans

• Entry of other therapies has increased disease awareness and diagnosis, expanding the potential patient pool.

• Lanifibranor is positioned as a foundational therapy for F2/F3 MASH patients, especially those with diabetes or high risk of progression.

• Plans to extend clinical investigation into compensated cirrhosis (F4), addressing a rapidly growing and underserved population.

• Phase III trial design closely mirrors phase IIb but with longer treatment duration and a focus on F2/F3 patients.

• Long-term follow-up is built into the phase III program, with extension options for up to 96 weeks and beyond.