Inventiva Announces End of Patient Recruitment for its Phase IIa Trial in the Treatment of MPS VI
June 11, 2019
Daix (France), June 11, 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 end of patient recruitment for its Phase IIa iMProveS (improve MPS treatment) trial in Europe evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI).
A total of 20 patients have been included in this Phase IIa trial versus an initial target of 24. Given odiparcil’s mechanism of action, the Company believes that this number of patients is sufficient to evaluate odiparcil’s safety profile and its impact on relevant efficacy biomarkers (measurement of glycosaminoglycans (GAGs) in the urine, skin and leukocytes) as well as to identify first signs of clinical efficacy in patients receiving enzyme replacement therapy (ERT) and in non-ERT treated patients. Therefore, Inventiva plans to amend the study protocol to update the target patient population to 20 subjects.
The patients included in the trial are distributed among the various arms, with fifteen patients being treated with ERT and receiving one of the two doses of odiparcil or placebo and five patients not being treated with ERT and only receiving the high dose of odiparcil. The headline results of the double-blind placebo controlled arms, which include the fifteen ERT-treated patients, are expected by the end of the year. Results of the open label cohort, which includes the five patients not being treated with ERT and only receiving the high dose of odiparcil, are expected during Q1 2020 given that the last patient for this subgroup was included in May 2019.
Marie-Paule Richard, M.D., Chief Medical Officer of Inventiva, stated: “We are delighted to have achieved this number of very rare disease patients and we are grateful to them and the clinicians participating in this trial. MPS VI is an orphan, and very debilitating disease, with current treatment still leaving patients with high unmet medical needs. Odiparcil has the potential to improve clinical manifestations of the disease, especially in tissues and organs where the efficiency of current treatments is limited. Odiparcil’s oral formulation could also be a great improvement for patients compared to current weekly infusions required for ERT. We look forward to obtaining the results of this Phase IIa trial to evaluate early signals of odiparcil’s efficacy in the treatment of MPS VI and, if positive, to pursue its development.”
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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