Clinical Trials

Date: 2017-05-15

Type of information: Results

phase: preclinical

Announcement: results

Company: Inventiva Pharma (France)

Product: IVA337 - lanifibranor - 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid)

Action mechanism:

PPAR modulator. This compound is a peroxisome proliferator activated receptors (PPAR) modulator. It has demonstrated anti-fibrotic properties in several tissues alongside good clinical tolerance. Its unique mechanism of action goes through the activation of all three alpha, gamma and delta PPARs to slow, halt or reverse the progression of fibrosis.
IVA337 has received orphan drug status for the treatment of systemic sclerosis in Europe and the United States.
Inventiva is currently conducting Phase IIb clinical trials with IVA337 in both NASH and systemic sclerosis, and results are expected in the second half of 2018.

Disease:

Therapeutic area:

Country:

Trial details:

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.

Latest news:

• On May 15, 2017, Inventiva announced the results of a 12 month non-human primate toxicology study with IVA337, a pan PPAR agonist in phase IIb clinical development in non-alcoholic steato-hepatitis (NASH) and systemic sclerosis. 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.
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.
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.