Inventiva announces completion of patient visits for its Phase IIb clinical study with lanifibranor in NASH
March 17, 2020
Daix (France), March 17, 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 announced the last visit of the last patient out of the 247 patients enrolled in its Phase IIb clinical study with lanifibranor in NASH. The last patient biopsy was performed in February and the last safety visit took place in the United States on March 16, 2020. All biopsies have been analysed by the central hepatologist and the publication of the study head-line results is planned in June 2020, in line with Company’s expectations.
The NATIVE (NAsh Trial to Validate IVA337 Efficacy) trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical study evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (NASH). The main purpose of the study is to assess the efficacy of lanifibranor in improving liver inflammation and ballooning, the two histological markers included in the definition of the regulatory endpoint of NASH resolution. Secondary endpoints of the study also include NASH resolution and improvement in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline.
Throughout the study, the safety profile of lanifibranor has been regularly assessed by an external, independent Data Safety Monitoring Board (DSMB). Four meetings of the DSMB took place between June 2018 and September 2019 and as no safety issues were reported, the DSMB repeatedly recommended the continuation of the study without any modification of the protocol, thus confirming the good safety profile of lanifibranor.
Prof. Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and co-principal investigator of the study, said: “With this last milestone before the publication of the study results achieved on schedule, I am very delighted to see that the trial is progressing as planned. The commitment and the quality of the work delivered by the clinicians and centers involved in the trial have been outstanding and I am sure this will result in high quality data. I am eager to see the results of this trial and to continue working on the development of lanifibranor.”
Prof. Manal Abdelmalek, M.D., M.P.H. from Duke University and co-principal investigator of the study with Prof. Sven Francque, added: “I am very pleased to have completed this last patient visit and I am proud of our team who has been able to accelerate patient enrollment in the United States. The profile of lanifibranor, as a drug candidate that could prove beneficial to NASH patients worldwide, is strong and compelling. I look forward to the successful completion of this study and the upcoming publication of the study head-line results.”
Pierre Broqua, CSO and cofounder of Inventiva, stated: “Backed by the solid design and roll-out of the NATIVE clinical study and the preclinical and clinical results generated by lanifibranor so far, we are convinced that its profile as a pan-PPAR agonist and its ability to combine the beneficial effects of all three PPAR isoforms constitute a clear advantage in the treatment of NASH. These characteristics give our leading drug candidate a differentiated mechanism of action that should enable it to meet the efficacy endpoints of our Phase IIb clinical study. We are looking forward to publishing the head-line results in the next few months, which, if positive, will support the launch of the pivotal Phase III study with 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.
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