お知らせ • Jul 03
Inventiva Announces the Publication in Journal of Hepatology Reports on Results of Lanifibranor Treatment on Liver Sinusoidal Endothelial Cells in Patients with MASLD/MASH and in Preclinical Models of the Disease
Inventiva announced the publication in Journal of Hepatology Reports, a peer-reviewed, scientific journal, of results from the Phase 2b NATIVE clinical trial and preclinical study evaluating the effects of lanifibranor on liver sinusoidal endothelial cells in Metabolic dysfunction-associated steatotic liver disease ("MASLD") and MASH. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected U unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing and to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of its product candidate, lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva's clinical trials, Inventiva's expectations With respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability To identify additional products or product candidates with significant commercial potential, Inventiva's expectations. Inventiva's ability to identify additional products or product candidate claims, Inventiv's expectations with respect to its patients with MASLD/MASH may not be realized and will not support the approval of a new Drug Application, Inventiva' ability to identify additional products or products or product candidates with significant Commercial potential, Inventiva's plans with respect to the New Drug Application, Inventiv's ability to identify additional products and its partners' product candidates with significant commercial potential. Inventiva's expectations with regards to the clinical development plan forlanifibranor for thetreatment of MASH may not be realize and may not support the approval the approval of a New Drug application, Inventiva's ability of a New Drug Application, inventiva's ability to identify further identify additional products or product candidates With significant commercial potential, Inventiv's expectations With respect to the commercialization of its product candidate claims, Inventive's expectations with respect to its commercialization of its product candidates, Inventiva's clinical trials may require additional holds and/or/or additional amendments to In ventiva's clinical trials, In ventiva's expectations with respect to the clinical development plan of lanifibranor for The treatment of MASH may be realized and may be realized and may not support The approval of a New Drug Application. Inventiva's capabilities with a New Drug Application, in a New Drug Application, In ventiva's ability to identify additional product candidate, Inventiva's capabilities with significant commercial potential, In Ventiva's ability to detect additional products or product candidates with a New Drug Application, In Ventiva's capabilities with significant commercialization of a New Drug Application.