- Implementation of a series of measures to promote employee safety and support local community
- Publication of top-line results of the Phase IIb NATIVE clinical trial for lanifibranor in NASH on track for June 2020
- Strong cash position with cash runway until the end of Q2 2021, beyond the next anticipated key clinical milestones of the Company
Daix (France), April 7, 2020 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today provided an update on its business activities and financial position as well as the initiatives announced to support its employees and the local community amid the evolving COVID-19 pandemic, all while promoting the continuity of essential work on the development of its R&D portfolio.
Employee update and initiatives to support local community
Following the recommendations of domestic public health authorities, Inventiva has implemented a series of measures to minimize risks for its employees and support their health and safety in this uncertain time. The Company has put on hold non-essential pre-clinical activities and implemented a work from home policy for most of its employees, including those engaged in research and development functions. Only a very limited presence is maintained on-site to enable the Company to quickly and efficiently restart full activities following the COVID-19 pandemic.
In addition, Inventiva supports the Dijon University Hospital as well as health care professionals in the region in the fight against COVID-19 by providing them with masks and protective gear.
As of today, no employees have been infected with COVID-19 to the knowledge of the Company.
R&D portfolio update
Lanifibranor in non-alcoholic steatohepatitis (NASH)
Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical study
To date, the Company does not anticipate that the COVID-19 pandemic will significantly impact Inventiva’s Phase IIb NATIVE clinical trial evaluating lanifibranor in the treatment of NASH. Following the completion of patient visits and the analysis of all exit biopsies announced on March 17, 2020, the publication of the trial top-line results remains on track for June 2020, in line with the Company’s expectations.
Phase II NAFLD clinical study
Regarding the ongoing Phase II clinical trial conducted by Dr. Kenneth Cusi1 and evaluating lanifibranor in the treatment of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes, patients already included in the trial continue to receive their treatment according to the established protocol. The recruitment and screening of new patients has, however, been suspended across all sites of the University of Florida due to the COVID-19 pandemic. At this stage, Inventiva cannot properly assess the impact of the pandemic on the overall timing of the trial.
It is important to note that any delay of this trial will not impact the further development of lanifibranor in the treatment of NASH and its potential move into a pivotal Phase III clinical trial following the publication of the Phase IIb NATIVE clinical trial results.
Odiparcil in mucopolysaccharidosis type VI (MPS VI)
Following the publication of positive results of the Phase IIa iMProveS (improve MPS treatment) clinical trial evaluating odiparcil in the treatment of MPS VI at the end of 2019, Inventiva remains fully focused on the preparation and launch of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in children with MPS VI, which is anticipated to commence prior to the end of 2020. However, given that regulatory authorities, hospitals and other relevant bodies are currently mobilized around the COVID-19 pandemic, it is possible that the COVID-19 pandemic will adversely impact the commencement of this trial.
YAP-TEAD in the field of oncology
Given the slowdown in pre-clinical activities, Inventiva cannot exclude a delay in the selection of a pre-clinical candidate for its YAP-TEAD program. At this stage, it is too early for the Company to be able to properly assess the impact of the COVID-19 pandemic on the timing of this program.
Thanks to its cash position which amounted to €35.8 million as at December 31, 2019, combined with the €15.0 million capital increase completed in February 2020, the Company confirms its cash runway until the end of Q2 2021, beyond the next anticipated key clinical milestones.
The global pandemic of COVID-19 continues to rapidly evolve and its ultimate impact is highly uncertain. The Company cannot predict the full extent of potential delays or impacts on its clinical trials, or potential impact on its business. As the Company navigates these unprecedented circumstances, Inventiva is committed to continuing to implement measures aimed at minimizing any further potential business impact from the COVID-19 pandemic and will continue to comply with the recent guidance documents of the regulatory authorities. The Company will continue to closely monitor, assess and respond to the situation as it evolves overtime and continue to work closely with its contract research organizations, trial sites and investigators to critically reassess all its existing programs and will communicate further when and if appropriate.
Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of diseases with significant unmet medical needs in the areas of fibrosis, lysosomal storage disorders and oncology.
Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates – lanifibranor and odiparcil – in non-alcoholic steatohepatitis (“NASH”) and mucopolysaccharidosis (“MPS”), respectively, as well as a deep pipeline of earlier stage programs.
Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies.
Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with MPS, a group of rare genetic disorders. A Phase I/II clinical trial in children with MPS VI is currently under preparation following the positive results of the Phase IIa clinical trial in adult MPS VI patients published at the end of 2019.
In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.
The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also 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 C of the regulated market of Euronext Paris (Euronext: IVA – ISIN: FR0013233012). www.inventivapharma.com
Chairman & CEO
+33 3 80 44 75 00
Yannick Tetzlaff / Tristan Roquet Montegon /
+33 1 53 96 83 83
Westwicke, an ICR Company
Patricia L. Bank
+1 415 513 1284
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, and anticipated future performance of Inventiva, the potential effects of COVID-19 on the Company's clinical trials and business strategy and of the market in which it operates. 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” 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual 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. Given these 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 Reference Document filed with the Autorité des Marchés Financiers on February 7, 2020 under n° D.20-0038 for additional information in relation to such factors, risks and uncertainties.
Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
1 Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida, Gainesville.
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