No adverse clinical signs observed during the treatment period regardless of the dose
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Aix (France), may 15, 2017 18: 00 CEST Inventiva, a biopharmaceutical company specializing in the development of innovative treatments, including fibrosis, today announced the results of the toxicological study of 12 months in non-human primates on its main drug candidate, IVA337, an agonist of pan-PPAR currently in phase IIb clinical development in non-alcoholic steatohepatitis (NASH) and the systemic sclerosis. During the period of treatment and at any dose, no adverse clinical signs, including those usually associated with thiazolidinediones were observed.
This toxicological study was conducted to meet the regulatory requirements of health authorities, including the FDA and the EMA. Inventiva leads also currently involved in two studies of carcinogenicity for 24 months in rodents, and after 18 months of treatment, the two studies are proceeding as planned. When these studies are completed, Inventiva will then have mid-2018 the folder toxicology that are required to initiate the phase III studies and apply for authorisations for the placing on the market.
“These results will be important for discussions of end of phase IIb as we have with the regulatory authorities. Inventiva is continuing to pursue its strategy which is to prepare IVA337 for the pivotal studies for registration in the NASH and systemic sclerosis, ” says Dr Pierre Broqua, Chief scientific officer and co-founder of Inventiva. “We are impressed by the safety profile of IVA337, which does not show adverse effects usually observed with thiazolidinediones or fibrates,” says Dr. Jeri El-Hage, Toxicologist, Consultant and Regulatory specialist in the field of PPARs within Aclairo Pharmaceutical Development Group.
Main results
No adverse clinical signs were observed during the treatment period, whatever the dose tested,
There were no effects on body weight or the weight of the heart, not of hemodilution or increased creatinine,
Electrocardiography did not reveal any treatment-related adverse effects by IVA337,
Ophthalmic examinations revealed no treatment-related adverse effects by IVA337,
The studies of clinical pathology (hematology, biochemistry and urine analysis) revealed no treatment-related adverse effects by IVA337.
The study protocol
The objective of this study was to evaluate the tolerance profile of IVA337 after daily oral administration to Cynomolgus monkeys for 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. At the end of the treatment period, animals designated were maintained without treatment for a period of 6 weeks to evaluate the reversibility of potential adverse effects.
Inventiva is currently conducting clinical studies of phase IIb with IVA337, both in the NASH and systemic scleroderma, for expected results during the second half of 2018. In previous clinical studies carried out with IVA337, the drug was well tolerated and showed a good safety profile, including a lack of effect on blood levels of creatinine, liver parameters, CPK, blood pressure, hemodilution, or weight gain.
About Inventiva : www.inventivapharma.com
Inventiva is a biopharmaceutical company specializing in the development of drugs acting on nuclear receptors, transcription factors and epigenetic modulation. Inventiva opens new avenues for innovative therapies in the field of fibrotic diseases, oncology, and orphan diseases for which the medical need is important.
Its flagship product, IVA337, is a drug candidate that has a unique mechanism of action through activation of the PPAR (receptor activated peroxisome proliferator -) alpha, gamma and delta, which play a fundamental role in the control of the fibrotic process. Its anti-fibrotic in particular allows you to target two indications to strong medical need : the NASH, a severe pathology of the liver in strong growth and which already affects the United States more than 30 million people, and the systemic scleroderma, a disease in which the mortality rate is very high and without any treatment approved to date.
Inventiva is developing in parallel a second clinical program with IVA336, a drug candidate for the treatment of three forms of mucopolysaccharidoses (MPS I, or syndrome, Hurler-Scheie, MPS II, or syndrome, Hunter and MPS VI or Maroteaux-Lamy syndrome), as well as a portfolio of pre-clinical projects in the field of oncology. Inventiva is surrounded by well-known partners in the area of the research, such as the Curie Institute. Two strategic partnerships, one of which at the clinical stage, have also been put in place with AbbVie and Boehringer Ingelheim, which include, in particular, for the payment to Inventiva of payments based on the achievement of objectives pre-clinical, clinical, regulatory and commercial, as well as royalties on sales of products developed in the framework of these partnerships.
Inventiva employs more than 100 highly qualified people and has R&D facilities of cutting edge purchased at the international pharmaceutical company Abbott, regrouping, near Dijon, a chemical library of more than 240 000 molecules and platforms in biology, chemistry, ADME, and pharmacology.
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