Inventiva announced that it has lifted the previously disclosed 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. Inventiva received the first approval from the central IRB overseeing clinical research in the United States. Clinical sites located in the United States operating under central IRB have meanwhile resumed screening and randomization activities.

This is an important milestone as 152 sites of the NATiV3 clinical trial sites are operating under central IRB and have so far randomized over 60% of the patients in the main cohort. Inventiva expects to progressively obtain the approvals required by local authorities to restart screening and randomization in other countries over the next few weeks. Prior to the voluntary pause, 913 patients were already randomized in the NATiV3 clinical trial including 731 in the main cohort and over 550 patients were in screening.