Inventiva S.A. (IVA) Q4 2023 Earnings Call

Investor webinar replay

Replay transcript excerpt

Thank you, good morning, good afternoon, everybody, and thanks for joining us today for this webcast. Before we begin, as usual, I ask you to please read the disclaimer on slide two, which should appear now, and I want to remind everyone that the various statements that we may make during today's conference or during the Q&A session will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Today, in this call, I'm joined by Jean, Jean Boulatier, our CFO, and by our CFO and co-founder, Pierre Broca. So let me go back to some of the highlights of Lani Fiber Nord development program by starting by 1983. So in January 23, we announced some important changes to the design of the phase three, evaluating Lani inpatient with MASH-NASH. which made the study more attractive for the site and especially more patient-friendly. This new design is based on discussion we had with the FDA and on the alternative approach put forward by the US FDA, which includes two independent phase three, one based on histological outcomes, native three, which would allow us, if our results are positive, to fight for accelerated approval. And the second phase three study in patients with MASH, NASH, and compensatory cirrhosis, which will be our confirmation trial in order to demonstrate clinical outcomes and which would secure a positive full approval. As part of the development of Lani, we were pleased that our partner, Sinobiopharm, received their IND approval by the Chinese and MPA to initiate the clinical development in China. Sinobiopharm is participating to our Global Native III Phase III clinical trial, and we have closed 2023 with the first patient enrolled in China and also a breakthrough therapy designation granted by the NMPA in Ch...