NATIVE PHASE IIB TRIAL
Non-alcoholic steatohepatitis (NASH) is a severe and chronic form of non-alcoholic fatty liver disease (NAFLD). It is estimated that 40% of NAFLD patients will progress to NASH, a disease defined as the presence of hepatic steatosis with hepatic inflammation and hepatocyte injury or ballooning, with or without fibrosis. NASH may progress to cirrhosis, liver failure and in some cases to hepatocellular carcinoma (HCC).
The NATIVE trial (NAsh Trial to Validate IVA337 Efficacy) is a randomized, double-blind, and placebo-controlled 24-week multicentre Phase IIb clinical study evaluating lanifibranor (formerly known as IVA337) in the treatment of NASH.
The study includes two active dose arms (800 and 1200 mg of lanifibranor) and a placebo comparator arm. The primary endpoint is a decrease from baseline of inflammantion and ballooning without worsening of fibrosis.
The study is currently ongoing in 16 countries worldwide and more than 70 centres have been selected. Patients are being recruited and headline results are expected in the second half of 2019.
FASST PHASE IIB TRIAL
Systemic sclerosis (SSc) is a complex, multiorgan, rare disease, affecting the immune system, the microvascular system and the connective tissue. This disease involves mostly the skin but also lung, heart, gastrointestinal tract and kidneys. Progressive organ failures make SSc a severe and lethal disease with a high death toll. The most common cause of death amongst SSc patients is pulmonary arterial hypertension (PAH), interstitial lung disease (ILD), or a combination of both. Compared to the general population, SSc patients die 22 to 26 years earlier.
The FASST (For A Systemic Sclerosis Treatment) study is designed to evaluate lanifibranor in the treatment of SSc and compare for 48 weeks two doses of lanifibranor with a placebo control level. Recruitment has been completed for this trial and headline results are expected early 2019.
The primary endpoint is the mean change of the MRSS (Modified Rodnan Skin score) from baseline to 48 weeks.
For further information on the FASST clinical trial, please visit https://clinicaltrials.gov/ with the identifier NCT02503644.
IMPROVES PHASE IIA TRIAL
Mucopolysaccharidoses (MPS) are a group of rare genetic disorders characterized by a deficiency of lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs).
The iMProveS (improve MPS treatment) trial is designed as a 26 week, double blinded, randomized, placebo-controlled Phase IIa clinical study to investigate the safety, pharmacokinetics and efficacy of oral administration of odiparcil in adult patients with MPS type VI, currently receiving enzyme replacement therapy (ERT). The study has also an open label arm with patients currently not on ERT. The iMProveS trial is open and recruiting patients. Headline results are expected in the second half of 2019.
Inventiva is currently preparing a Phase Ib trial of odiparcil in children suffering from MPS VI. The study is called SAFE-KIDDS-MPS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study of odiparcil in pediatric population with mucopolysaccharidosis (MPS) type VI). It is expected to start in the fourth quarter of 2018.
Furthemore, Inventiva announced a lanifibranor investigator-initiated Phase II study by Dr. Kenneth Cusi, Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida, Gainesville. The study’s goal is to evaluate the efficacy and safety of lanifibranor (link to lanifibranor page) on intrahepatic triglycerides and hepatic insulin sensitivity in type 2 diabetic patients with non-alcoholic fatty liver disease (NAFLD). The trial is planned to commence enrolment in the second half of 2018. For a recording of a presentation on the study by Dr. Cusi, Pierre Broqua, CSO and co-founder of Inventiva, and Jean-Louis Abitbol, Chief Medical Officer of Inventiva, please click here.