Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lanifibranor
IVA337 · 5 trials · 7 indications
Part A: DBPC: Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline
Part B: ATE: * Using the DBPC on-treatment period, comparing the 2 active arms versus placebo * Using the DBPC +ATE on treatment periods, assessing the 2 active arms. For adverse events, adjudicated liver events, and DILI and MACE events, in addition to the raw cumulative incidence proportions, the exposure-adjusted incidence rates will be provided based on the time patients are at risk.
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
Effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24
SAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflamation score and balloning score. No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
Mean change of the MRSS from baseline
| Arm | Type | Description |
|---|---|---|
| Lanifibranor (IVA 337) (800 mg/day) | EXPERIMENTAL | 2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --\> once a day (quaque die, QD) |
| Lanifibranor (IVA 337) (1200 mg/day) | EXPERIMENTAL | 3 Lanifibranor tablets 400mg with food --\> once a day (quaque die, QD) |
| Matching placebo | PLACEBO_COMPARATOR | 3 Placebo to match tablets with food --\> once a day (quaque die, QD) |
| lanifibranor arm | ACTIVE_COMPARATOR | Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day. |
| Placebo | PLACEBO_COMPARATOR | Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo. |
| Lanifibranor (800 mg/day) | EXPERIMENTAL | Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each, once-a-day (QD) with food. For oral use. QD for 24 weeks. |
| Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day) | EXPERIMENTAL | Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each plus one empagliflozin film-coated tablet of 10 mg (10mg/day), once-a-day (QD) with food. For oral use. QD for 24 weeks |
| IVA337 1200mg | EXPERIMENTAL | IVA337 400mg, once a day (Quaque Die, QD) with food |
| IVA337 800mg | EXPERIMENTAL | IVA337 400mg, once a day (Quaque Die, QD) with food |
| Name | Type | Description |
|---|---|---|
| IVA337 | DRUG | A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B. |
| Placebo | DRUG | A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B. |
| Lanifibranor | DRUG | The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day |
| Empagliflozin | DRUG | 10 mg |
Prescreening Criteria: * Diagnosed with NASH on prior liver biopsy * Type 2 diabetes with high waist circumference or obesity or hepatic steatosis on ultrasound * At least 3 of the components of metabolic syndrome Inclusion Criteria: 1. Male or female, aged ≥18 years at the time of signing inform...
IVA337, also known as lanifibranor, is an investigational oral small molecule developed by Inventiva S.A. for metabolic and fibrotic diseases. It is being studied in nonalcoholic steatohepatitis (NASH) and diffuse cutaneous systemic sclerosis. It has not been approved by any regulatory agency.
IVA337 is being evaluated for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The Phase 3 NATiV3 trial is studying it in adults with NASH and fibrosis stages F2 and F3. It remains investigational and is not approved for any indication.
IVA337 targets PPARα, PPARδ, and PPARγ, three nuclear receptors involved in regulating lipid metabolism, inflammation, and fibrosis. This pan-PPAR mechanism is intended to address multiple pathways implicated in NASH and systemic sclerosis.
IVA337 is being developed by Inventiva S.A., a clinical-stage biopharmaceutical company. Its American Depositary Shares trade on the Nasdaq under the ticker IVA.
IVA337 is in Phase 3 development. The pivotal NATiV3 trial (NCT04849728) is active but not recruiting, with an enrollment of 1,000 participants. Earlier Phase 2 trials in NASH and diffuse cutaneous systemic sclerosis have been completed.
IVA337 has been studied in three registered trials. The Phase 3 NATiV3 trial (NCT04849728) is ongoing in NASH with fibrosis. Completed trials include a Phase 2b NASH study (NCT03008070) and a Phase 2 proof-of-concept trial in diffuse cutaneous systemic sclerosis (NCT02503644).