Inventiva To Change Clinical Development of Its Lead NASH Candidate
- Inventiva has decided to modify the clinical development plan of lanifibranor for non-alcoholic steatohepatitis (NASH).
- The changes follow a consultation with the FDA, Inventiva said.*
- Inventiva had initially designed a two-part study where part one would support accelerated approval with data from 900 patients, and part two would follow 2,000 patients for up to seven years.
- The company is now replacing part 2 with a new, separate Phase 3 trial that will enroll around 800 patients and last for about three years.
- Part one of the NATiV3 study should provide data on liver histology from tissue biopsies. Enrollment is set to be completed in the second half of 2023, and patients will be followed for 72 weeks.
- If the results are positive, the company anticipates it will support submitting a marketing application for full approval and the potential expansion of the addressable patient population beyond patients with F2 and F3 fibrosis.
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