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Inventiva announced design of Phase 3 clinical trial with lanifibranor in NASH
06 Jan 2021
Inventiva – Lanifibranor (pan-PPAR agonist, Phase 3)
- Inventiva planned a single global Phase 3 (NATIVE3) trial evaluating two doses of lanifibranor (800 mg and 1200 mg once daily) versus placebo
- Trial design and clinical strategy was discussed with both FDA and EMA following the end-of-Phase 2 meeting
- The primary endpoint is a composite one combining NASH resolution and ≥1 stage fibrosis improvement, based on 72-week histology analysis in ~900 patients
- The trial is on track to be initiated in H1’21
Inventiva announced the strategy for lanifibranor’s Phase 3 global trial and accelerated approval
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CI Scientists Remarks:
- Inventiva’s lead product lanifibranor is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression
- Results from Phase 2 trial
Results from the NATIVE Phase IIb trial: ITT (intention-totreat) population | 800 mg (N = 83) | 1200 mg (N = 83) | Placebo (N = 81) |
Patients with both resolution of NASH and improvement of fibrosis | 21% P=0.017 | 31% P<0.001 | 7% |
Results from the NATIVE Phase IIb trial: ITT population and patients with F2/F3 fibrosis | 800 mg (N = 68) | 1200 mg (N = 63) | Placebo (N = 57) |
Patients with both resolution of NASH and improvement of fibrosis | 24% P = 0.012 | 33% P < 0.001 | 7% |
Results from the NATIVE Phase IIb trial: ITT population and patients with TD2M | 800 mg (N = 33) | 1200 mg (N = 35) | Placebo (N = 35) |
Patients with both resolution of NASH and improvement of fibrosis | 24% P = 0.012 | 29% P = 0.003 | 3% |
- Inventiva planning to seek accelerated (US) and conditional approval (EU) for lanifibranor if they see positive intermediary trial results
- With its convenient dosage regimen, Inventiva is hoping to position lanifibranor as a drug that induces NASH resolution and fibrosis, and a choice of two doses offering doctors the ability to use a lower dose without compromising the efficacy and to control side-effects such as edema
– Akshat Gulati, CI Scientists