France-based Inventiva S.A. and China’s Chia Tai Tianqing have filed a clinical trial application with the Center for Drug Evaluation (CDE) for their Category 1 drug, lanifibranor. The application has been accepted for review. Lanifibranor is an oral peroxisome proliferator-activated receptor (PPAR) agonist designed to treat non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Licensing Deal and Development Rights
The drug was the focus of a licensing deal between Inventiva and Chia Tai Tianqing in September last year. Chia Tai Tianqing holds the development, manufacturing, and commercialization rights for lanifibranor in Greater China. Lanifibranor has previously obtained breakthrough therapy designation (BTD) and fast-track statuses in the United States.
Clinical Trial Results and Ongoing Studies
Lanifibranor has demonstrated good safety and tolerability in multiple ongoing clinical trials. In the Phase IIb NATIVE trial, treatment with lanifibranor 1200 mg/day for 24 weeks significantly reduced the SAF-A (activity of steatosis, activity, and fibrosis) score in obese patients with confirmed NASH by biopsy. The study also reached several secondary endpoints. According to ClinicalTrials.gov, the drug is currently subject to multiple late-stage clinical trials, including Phase III trials in NASH and stage II or III hepatic fibrosis, as well as a Phase II study in NASH or NAFLD with type 2 diabetes.
Significance of the CDE Filing
The acceptance of the clinical trial application by the CDE marks a significant milestone in the development of lanifibranor. This progress highlights the potential of the drug to offer effective treatment options for patients with NAFLD and NASH, two conditions with significant unmet medical needs. The collaboration between Inventiva and Chia Tai Tianqing aims to accelerate the development and availability of lanifibranor in the Chinese market.-Fineline Info & Tech
