Inventiva S.A. (NASDAQ:IVA) Q4 2023 Results Conference Call March 28, 2024 8:00 AM ET
Company Participants
Frederic Cren - CEO
Jean Volatier - CFO
Conference Call Participants
Seamus Fernandez - Guggenheim Securities
Rami Katkhuda - LifeSci Capital
Lucy Codrington - Jefferies & Co.
Jacob Mekhael - KBC Securities
Operator
Good day and thank you for standing by. Welcome to the Inventiva Annual Results 2023 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. [Operator Instructions]. Please be advised that today's conference is being recorded.
I would now like to hand the conference over to your speaker today. Frederic Cren, please go ahead.
Frederic Cren
Thank you. Good morning. Good afternoon, everybody, and thank you 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 various statement that we may make during today's conference or during the Q&A session will include forward-looking statement within the meaning of the Private Securities Litigation Reform Act of 1995. Today in this call, I'm joined by Jean Volatier our CFO and by our CFO and Co-founder Pierre Broqua.
So, let me go back to some of the highlights of lanifibranor development program by starting by NATiV3. So, in January 23, we announced some important changes to the design of the Phase 3 evaluating lani in patient 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 3, one based on histology outcomes, NATiV3, which would allow us if our results are positive to file for accelerated approval.
And the second Phase 3 study in patient 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, Sino Biopharm, received their ILD approval by the Chinese and MPA to initiate the clinical development in China. Sino Biopharm is participating to our global NATiV3 Phase 3 clinical trial, and we have closed to 7.23 with the first patient enrolled in China and also a breakthrough therapy designation granted by the NMPA in China. Making lani the first drug candidate to our knowledge to receive such designation from both the FDA and the NMPA for the treatment of MASH/NASH.