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Daix (France), Long Island City (New York, United States) / Paris (France) and Waltham (United States), June 8, 2023 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis (“NASH”) and other diseases with significant unmet medical needs and Echosens, a high-technology company providing a comprehensive range of diagnostic solutions for liver health, today announce their collaboration in raising awareness about NASH and increase access to screening for patients at risk of developing NASH.
NASH is a chronic and progressive metabolic liver disease that, if left undiagnosed and unmanaged, can lead to cirrhosis or liver cancer and may result in the need for a liver transplant. Although NASH is often described as “silent”, patients with NASH do have an impaired quality of life1 and an increased risk of cardiovascular and liver-related complications2.
With a global prevalence ranging from 1.5% to 6.45%3 and expected to increase 63% by 20303, there is an urgent need to diagnose patients at higher risk of progression. This is why Inventiva and Echosens are joining forces to provide easier access to screening using FibroScan® in local communities. This awareness and screening program will take place in about ten communities at risk for NASH in the United States and Europe, and will be supported by expert hepatologists and local patient and community organizations.
Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “On this 6th annual edition of International NASH Day, we are extremely proud to join forces with Echosens in this effort to increase both NASH awareness and identification of patients at risk of developing NASH. A tremendous effort is still required to ensure that patients are not left undiagnosed and that they eventually receive the care that they need. We are delighted to combine our expertise in the development of potential therapies for NASH together with Echosens’ world-class know-how in NASH diagnosis, for this initiative that will shed further light on this disease and help screen and identify patients at risk of developing NASH.”
“There is a pressing need for a broader adoption of non-invasive liver tests to increase the diagnosis rate and improve the care of people living with NASH. We, alongside with our partners, have a joint responsibility to shape a future where patients have access to easy diagnosis solutions and effective therapies” said Dominique Legros, CEO of Echosens. “We are very proud to partner with Inventiva to launch initiatives facilitating screening of NASH and increasing awareness of this disease among patients, healthcare providers and other stakeholders.”
Non-alcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD). It is a progressive metabolic liver disease characterised by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, and eventually end-stage liver disease and death. The risk of progression to advanced liver disease, including liver cancer, is higher in people with NASH than in the general population, and NASH is already the leading cause of waitlist registration and liver transplant in women in the United States4. Moreover, NASH increases the risk of developing cardiovascular diseases5. Known risk factors for NASH include dyslipidaemia, type 2 diabetes, obesity, metabolic syndrome and hypertension. There are currently no approved treatments for NASH globally, and people with NASH are left with very few management options.
Pioneer in its field, Echosens significantly changed the practice of liver assessment with FibroScan®, the non-invasive solution for comprehensive management of liver health. For the past decade, FibroScan® has been recognized worldwide and validated by over 3,500 peer-reviewed publications and 160 international guidelines. Echosens has made FibroScan® available in over 100+ countries enabling millions of liver examinations worldwide.
At Echosens we envision a future where…
… liver health is at the core of total health,
… every medical professional has the necessary tools to measure the health of the liver, identify pathologies, and manage treatments simply, accurately and effectively,
… every patient has the right to receive information about their liver health in a simple, timely,
and easy-to-understand manner.
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with NASH, mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies.
Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting an oncology development candidate for its Hippo signalling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA).
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This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s pre-clinical programs and clinical trials, including design, duration, timing, recruitment costs, screening and enrolment for those trials, including the ongoing NATiV3 Phase III clinical trial with lanifibranor in NASH, the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes and the study with lanifibranor in patients with NAFLD and T2D, potential development of and regulatory pathway for odiparcil, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of Inventiva’s product candidates, including lanifibranor, potential regulatory submissions and approvals, and Inventiva’s pipeline and preclinical and clinical development plans, future activities, expectations, plans, growth and prospects of Inventiva, the potential receipt of the second tranche under the EIB loan and any potential transaction or receipt of additional funds, future access to the two-year short-term deposit, and the sufficiency of Inventiva’s cash resources and estimated cash runway. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to pipeline 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 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 future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s clinical trials may not support Inventiva’s product candidate claims, Inventiva’s expectations with respect to the changes to the clinical development plan for lanifibranor for the treatment of NASH may not be realized and may not support the approval of a New Drug Application, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva to recruit and retain patients in clinical studies, enrolment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current geopolitical events, such as the conflict between Russia and Ukraine, related sanctions and related impacts and potential impacts on the initiation, enrolment and completion of Inventiva’s clinical trials on anticipated timelines, health epidemics, and macroeconomic conditions, including global inflation, rising interest rates, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.
Please refer to the Universal Registration Document for the year ended December 31, 2022 filed with the Autorité des Marchés Financiers on March 30, 2023, and the Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 30, 2023 for other risks and uncertainties affecting Inventiva, including those described from time to time under the caption “Risk Factors”. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.
All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above.
1 Kennedy-Martin, T., Bae, J.P., Paczkowski, R. et al. Health-related quality of life burden of non-alcoholic steatohepatitis: a robust pragmatic literature review. J Patient Rep Outcomes 2, 28 (2018). https://doi.org/10.1186/s41687-018-0052-7
2 Dulai PS, Singh S, Patel J, Soni M, Prokop LJ, Younossi Z, Sebastiani G, Ekstedt M, Hagstrom H, Nasr P, Stal P, Wong VW, Kechagias S, Hultcrantz R, Loomba R. Increased risk of mortality by fibrosis stage in non-alcoholic fatty liver disease: Systematic review and meta-analysis. Hepatology. 2017 May;65(5):1557-1565. doi: 10.1002/hep.29085. Epub 2017 Mar 31. PMID: 28130788; PMCID: PMC5397356.
3 Estes C, Razavi H, Loomba R, et al. Modeling the epidemic of non-alcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018;67(1):123-133.
4 Noureddin M, Vipani A, Bresee C, Todo T, Kim IK, Alkhouri N, Setiawan VW, Tran T, Ayoub WS, Lu SC, Klein AS, Sundaram V, Nissen NN. NASH Leading Cause of Liver Transplant in Women: Updated Analysis of Indications For Liver Transplant and Ethnic and Gender Variances. Am J Gastroenterol. 2018 Nov;113(11):1649-1659.
5 Angulo P, Kleiner DE, Dam-Larsen S, et al. Liver fibrosis, but no other histologic features, associates with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2015;149(2):389-397.