Inventiva (IVA) 3rd Annual Guggenheim Healthcare Innovation Conference summary

NATiV3 readout and efficacy

• Phase III NATiV3 top-line results were expected this quarter; management described an 18% effect on the primary composite as a win.

• Phase II NATIVE results cited an 18% effect on fibrosis regression and a 24% effect on the composite requiring MASH resolution and fibrosis improvement.

• Management said the Phase III study was powered using a conservative treatment-effect and placebo-response estimate versus NATIVE data, with slight over-enrollment.

• The 800 mg and 1,200 mg doses were selected to assess potential efficacy and tolerability differences; management suggested they could suit different patient segments, pending results.

Clinical profile and safety

• Lanifibranor’s partial PPAR-gamma agonism was described as producing a more muted PPAR-gamma signature than full agonists such as pioglitazone.

• Phase II safety findings included weight gain, peripheral edema and some dilutional anemia; edema was cited at 7%-8%, versus mid-20s in a comparable pioglitazone trial.

• No muscle, myopathy, creatine kinase or kidney signal associated with PPAR-alpha or delta was reported in Phase II.

• The data safety monitoring board had recommended continuing the trial at each of nine reviews.

• Management cited HbA1c reductions of 0.4-0.5 percentage points and said metabolic markers may complement histologic benefits.

Patient opportunity and commercialization

• By a potential launch, management estimated ~400,000 physician-treated F2/F3 patients; roughly half were F2, half F3, and 55%-60% had diabetes.

• F3 patients and patients with diabetes together represent ~75% of the market; the F3 diabetic segment was estimated at about one-third.

• Following positive data, management plans to begin NDA preparation immediately, has targeted filing in H1, and anticipates launch in 2028.

• Gastroenterologists and hepatologists account for 80% of current prescribing volume and are the initial commercial focus; endocrinologists are also under consideration.

• Management expects a growing combination-therapy market, potentially pairing an injectable such as a GLP-1 therapy with an oral treatment for F2/F3 disease.