Inventiva is developing lanifibranor for the treatment of NASH to address all the key features of this disease: accumulation of liver fat (steatosis), inflammation (hepatitis), injury of liver cells (ballooning), as well as scarring of the liver (fibrosis) that can ultimately lead to cirrhosis. The progression of fibrosis to cirrhosis, and its complications, is especially relevant in determining the outcome of the disease with regard to morbidity and survival.

Lanifibranor has completed a phase IIb study. After 6 months of treatment, lanifibranor showed statistically significant efficacy for the regulatory endpoints required by FDA and EMA: resolution of NASH* without worsening of fibrosis, reduction in fibrosis without worsening of NASH** and in the composite endpoint of patients achieving resolution of NASH with improvement in fibrosis. These efficacy results, together with a favorable safety profile, led to Breakthrough Therapy Designation by the FDA. For more details of the headline results see the results presentation.

Based on the positive results of the phase IIb study, Inventiva has initiated a pivotal phase III clinical trial, NATiV3, evaluating lanifibranor for the treatment of NASH.
[Clinicaltrials.gov NCT04849728].

* Resolution of NASH and no worsening of fibrosis at week 24: NAS-I = 0 or 1 (NAS-Inflammation), NAS-B = 0 (NAS-Ballooning) and no worsening of NAS-F from baseline (NAS-Fibrosis)

** Improvement of liver fibrosis ≥ 1 stage and no worsening of NASH at week 24

MPS is a group of rare genetic disorders characterized by an excessive accumulation of large sugar chains, known as glycosaminoglycans, or GAGs, in cells.

Inventiva is developing odiparcil, an orally-available small molecule designed to modify how GAGs are synthesized.

In the recently completed iMProveS phase IIa study, odiparcil confirmed its favourable safety profile and demonstrated efficacy in adult MPS VI patients, especially in tissues types not reached by standard of care.

Lanifibranor
Phase IIb trial in NASH, recruiting