Inventiva Announces Positive Results of 12 Month Primate Toxicity Study with IVA337
May 15, 2017
> No Adverse Clinical Signs Observed at Any Dose-Levels During the Treatment Period
Daix (France), May 15, 2017 – 6:00pm CEST –Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today the results of a 12 month non-human primate toxicology study with its lead drug candidate IVA337, a pan PPAR agonist in phase IIb clinical development in non-alcoholic steato-hepatitis (NASH) and systemic sclerosis (SSc). No adverse clinical signs were observed during the treatment period at any dose-level and none of the typical adverse effects related to the thiazolidinones were observed.
This toxicology study was conducted to meet the regulatory requirements of health authorities including the FDA and EMA. Inventiva is also advancing with two carcinogenity studies of 24 month duration in rodents, and after 18 months of treatment both studies are progressing as planned. Once these are completed, Inventiva will have by mid-2018 the necessary toxicology package required to move into Phase III testing and for regulatory filing.
“These results will be important for the end of phase IIb discussions with regulatory authorities. Inventiva continues to deliver on its strategy to have IVA337 ready to enter into pivotal trials in NASH and SSc,” said Dr. Pierre Broqua, Chief Scientific Officer and Cofounder of Inventiva. “We are impressed by the benign profile of IVA337, which does not show the side effects typically observed with thiazolidinediones or fibrates” added Dr. Jeri El-Hage, Toxicologist and Regulatory Consultant, expert in the PPAR field at Aclairo Pharmaceutical Development Group.
- No adverse clinical signs were observed during the treatment period at any dose-level tested,
- There were no effects on body weight and heart weight, no haemodilution or creatinine increase,
- Electrocardiography did not reveal any undesirable effects related to IVA337 treatment,
- Ophthalmological examinations did not reveal any undesirable effects related to IVA337 treatment,
- Clinical pathology investigations (hematology, clinical biochemistry and urinalysis) did not reveal any undesirable effects related to IVA337 treatment.
The objective of this study was to evaluate the safety profile of IVA337 following daily oral administration to cynomolgus monkeys over 52 weeks. Forty eight monkeys received a daily oral administration of IVA337 at doses of 100, 250 or 625 mg/kg/day or placebo for 52 weeks. On completion of the treatment period, designated animals were held for a 6-week treatment-free period in order to evaluate the reversibility of any findings.
Inventiva is currently conducting Phase IIb clinical trials with IVA337 in both NASH and SSc, and results are expected in the second half of 2018. In previous clinical studies with IVA337, the drug was well tolerated and safe, in particular there were no changes of creatinine blood levels, liver function tests, CPK, blood pressure, no signal of haemodilution or weight gain.
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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