Inventiva announces that screening in the NATiV3, phase III, clinical trial evaluating lanifibranor in NASH has resumed.
Inventiva a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, announced that it has lifted the previously disclosed1 voluntary pause on screening and randomization of its NATiV3 clinical trial and that sites are resuming screening activities.
Following the Suspected Unexpected Serious Adverse Reaction (“SUSAR”) in a patient enrolled in the study, Inventiva chose to voluntarily pause screening and randomization of new patients in the NATiV3 trial to implement the recommendations of the independent Data Monitoring Committee (“DMC”), which included liver monitoring every 6 weeks for each patient enrolled in the trial, and amending the protocol to exclude newly screened patients diagnosed or with a predisposition to autoimmune liver and thyroid disease. In addition, the Company has made amendments to the Informed Consent Form (“ICF”) in line with the DMC recommendations. During the pause, the DMC has continued to receive updates on the patient status and has reviewed and approved the amendments made to Inventiva’s study documents.
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