Clinical Trials

Date: 2017-01-03

Type of information: Initiation of patient enrollment

phase: 2

Announcement: initiation of patient enrollment

Company: Inventiva Pharma (France)

Product: IVA337 - lanifibranor - 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid

Action mechanism:

PPAR modulator. IVA337 is a peroxisome proliferator activated receptors (PPAR) modulator. It has demonstrated anti-fibrotic properties in several tissues alongside good clinical tolerance. Its unique mechanism of action goes through the activation of all three alpha, gamma and delta PPARs to slow, halt or reverse the progression of fibrosis.
IVA337 is currently in a Phase IIb trial for the treatment of systemic sclerosis, another fibrotic disease with very high unmet medical needs. IVA337 has undergone a successful Phase IIa study in diabetic patients with improvements in markers of insulin resistance (HOMA-IR), and dyslipidemia (increase in circulating HDL cholesterol and decrease of circulating triglycerides). Data generated in multiple relevant pre-clinical models demonstrated that IVA337 also positively impacts all hepatic lesions associated with NASH. In these pre-clinical studies, IVA337 significantly reduced steatosis, ballooning and inflammation, and reversed established liver fibrosis.

Disease: NASH (non-alcoholic steatohepatitis)

Therapeutic area: Hepatic diseases - Liver diseases

Country: Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, UK

Trial details:

Non-alcoholic steatohepatitis is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.(NCT03008070)

Latest news:

• On January 3, 2017, Inventiva announced the beginning of patient enrollment for its Phase IIb clinical trial (NATIVE - NASH Trial to Validate IVA337 Efficacy) evaluating IVA337, for the treatment of Non-Alcoholic Steatohepatitis (NASH). The study is a randomized, double-blind, placebo-controlled, multi-center, Phase IIb clinical trial in NASH patients. It will investigate the safety and efficacy of two doses of IVA337 (800 and 1200 mg/day) over a 24-week period and will enroll up to 225 patients in 12 European countries. The primary endpoint will be based on histologically assessed improvement of the activity component of the SAF2 score combining inflammation and ballooning, without worsening of fibrosis.