Inventiva achieves a major milestone by completing patient recruitment for its Phase IIb clinical study with lanifibranor in NASH
September 4, 2019
Daix (France), September 4, 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 successful completion of patient recruitment for its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH).
A total of 247 patients have been randomized in the Phase IIb NATIVE trial, exceeding the initial target of 225 patients following an acceleration of inclusions over the last months. Patients were mainly recruited in sites located in Australia, Canada, Europe and the United States. The objective to recruit patients with a severe form of NASH was met as approximately 73% among them have a NAS score greater than or equal to six and 76% have a F2 or F3 fibrosis score. In addition, the study population includes more than 40% of patients with type 2 diabetes (T2DM), allowing Inventiva to conduct the planned subanalyses in this key patient group, where lanifibranor as an insulin sensitizer should be particularly beneficial. It is estimated that approximately half of the NASH patients globally have T2DM, and are at greater risk of poor clinical outcomes. To date, 146 patients have already successfully completed the six-month study confirming that the treatment is well tolerated.
Having reached this key recruitment milestone, the publication of the study’s headline results is expected for H1 2020.
The completion of patient recruitment follows three meetings of the NATIVE DSMB (Data Safety Monitoring Board), which had reviewed patient safety data and repeatedly recommended the continuation of the trial without changing the protocol, confirming the favorable safety profile of lanifibranor. These positive outcomes are consistent with the results of long-term toxicological studies and Phase I and Phase II clinical trials, as well as with the FDA’s decision in May 2019 to lift the peroxisome proliferator-activated receptor (PPAR) target class-related clinical hold for lanifibranor.
Prof. Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and Co-Principal Investigator of the study, said: “Since the PPAR mechanism of action has already widely been validated for the treatment of NASH, and given lanifbranor’s unique profile as a pan-PPAR agonist, this drug candidate should be able to reduce NASH and the fibrosis associated with it as well as to provide metabolic benefits. The analysis of patients with type two diabetes will also be of importance to confirm that lanifibranor is particularly suited to this population.”
Prof. Manal Abdelmalek, M.D., M.P.H. from Duke University and Co-Principal Investigator of the study, stated: “The completion of patient recruitment in this international study is excellent news. The study has been well
conducted, and given the preclinical and clinical results generated by lanifibranor so far, we are confident that this treatment will prove to be a valuable approach to treat NASH patients.”
Marie-Paule Richard, M.D., Chief Medical Officer of Inventiva, added: “A great thank-you to all of the clinicians and patients participating in this international trial. The safety profile of lanifibranor and the way the study has been conducted so far are very encouraging. We are confident that this trial will reach its primary endpoint and we are looking forward to publishing the results in the first half of 2020, which, if positive, will support lanifibranor’s entry into the pivotal Phase III.”
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.
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