Inventiva receives FDA Fast Track designation for lead asset lanifibranor in NASH
September 26, 2019
Daix (France), September 26, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead product candidate, lanifibranor, for the treatment of non-alcoholic steatohepatitis (NASH).
The FDA’s dedicated Fast Track program is designed to facilitate the development and expedite the review and potential approval of drug candidates. Its overall objective is to improve patient access to therapies intended to treat serious conditions and to fill significant unmet medical needs.
Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: “We are delighted that the FDA has granted Fast Track designation to lanifibranor for the treatment of NASH. It highlights the large and unmet medical need for this common, progressive and severe chronic liver disease, for which there is currently no approved therapy. We are convinced of the unique mechanism of action of lanifibranor, the only pan-PPAR agonist currently in development, and its potential to treat NASH patients. Today’s decision represents an important step towards achieving our objective of getting appropriate therapy to patients as quickly as possible. We are pleased with the constructive and open dialogue we had so far with the FDA and we look forward to continue working closely together with them to accelerate the development of lanifibranor.”
Once a therapeutic product receives Fast Track designation, the respective company is eligible for more frequent communication with the FDA to discuss the drug candidate’s development plan, the design of the proposed clinical trials, the use of biomarkers, and the collection of appropriate data required to support drug approval. It also provides the respective company with accelerated approval and priority review, as well as rolling review meaning that the respective company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review, rather than waiting until every section of the BLA or NDA is completed.
The FDA’s decision follows the completion of patient recruitment for Inventiva’s NATIVE (NAsh Trial to Validate IVA337 Efficacy) Phase IIb clinical study evaluating the drug candidate for the treatment of NASH. The study is progressing as planned and the publication of the results are expected in the first half of 2020. If positive, they will support the entry of lanifibranor into the pivotal Phase III trial, the last phase of its development prior to market launch.
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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