Inventiva announces the positive recommendation of the 4 th and last DSMB of the Phase IIb clinical study with lanifibranor in NASH
Inventiva announces the positive recommendation of the 4 th
and last DSMB of the Phase IIb clinical study with lanifibranor in NASH
September 10, 2019
Daix (France), September 10, 2019 – 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 announced the positive recommendation of the fourth and last Data Safety Monitoring Board (DSMB) of the NATIVE Phase IIb clinical study evaluating lanifibranor in NASH. No safety issues were reported and, as for the first three DSMB meetings, the DSMB recommended to continue the study without changing the protocol. These conclusions are all the more significant as this safety assessment was based on the review of data from 228 patients, including 139 patients treated for the whole study period. This positive recommendation confirms once again the good safety profile of lanifibranor.
The Phase IIb clinical study NATIVE (NAsh Trial to Validate IVA337 Efficacy) evaluates lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH), a chronic and progressive liver disease for which there is currently no approved treatment. Following the positive conclusions of the last DSMB and the successful completion of patient recruitment in the study announced on 4 September 2019, Inventiva confirms the publication of the study results in the first semester 2020.
Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: “We are particularly satisfied with the safe profile of lanifibranor in patients with NASH. The DSMB’s recommendation, as well as the FDA’s decision to lift the clinical hold in place on PPAR agonists for lanifibranor, support the unique mechanism of action of our drug candidate. We look forward to the publication of the study results during the first half of 2020 and if positive, to initiate the last phase of development prior to the market launch of lanifibranor.”
Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.
Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.
Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.
Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.[/lvca_panel][lvca_panel panel_id=”panel-5bc0ba5831260″ panel_title=”Important Notice”]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 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 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.[/lvca_panel][/lvca_accordion]