Inventiva to provide an update on the NATIVE Phase IIb clinical trial in NASH during a Key Opinion Leader webcast
April 21, 2020
Daix (France), April 21, 2020 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (“NASH”), mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical need, today announced that it will host a webcast presentation with two Key Opinion Leaders on May 4, 2020 to provide an update on its Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor for the treatment of NASH ahead of the release of headline results, which is expected in June 2020.
With the participation of Prof. Sven Francque, M.D., Antwerp University Hospital, co-principal investigator of the NATIVE clinical trial, and Prof. Pierre Bedossa, M.D., Paris-Diderot University, the central pathologist in charge of the biopsy analyses of the NATIVE clinical trial, the Company will discuss the trial design and present the characteristics of the patient population. At this stage, the trial remains blinded, in line with the protocol.
During this event, which had initially been scheduled to take place during the International Liver Congress 2020 (European Association for the Study of the Liver), Inventiva will explain the methodology used for the analysis of patient biopsies in the NATIVE clinical trial, and compare the different screening approaches currently used in NASH clinical trials, in particular the Steatosis, Activity, Fibrosis (“SAF”) and NAFLD Activity Score (“NAS”) scoring systems.
Pierre Broqua, CSO and cofounder of Inventiva, said: “After the analysis of all biopsies in the NATIVE clinical trial announced in mid-March, this webcast represents the last event before the expected publication of the trial’s headline results in June 2020. Prior to the clinical data release, we would like to review the different aspects of the trial in detail and we are delighted to benefit, on this occasion, from the participation of Prof. Sven Francque and Prof. Pierre Bedossa, two highly recognized experts in the NASH field. In particular, we will focus on how the trial design and our innovative screening strategy based on the SAF score enabled us to meet our patient recruitment objectives, including a high percentage of patients with severe steatohepatitis associated with advanced fibrosis.”
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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