Date: 2012-02-08
Type of information: Results
phase: long-term animal toxicology studies
Announcement: results
Company: Genfit (France)
Product: GFT505
Action mechanism: PPAR agonist. Elafibranor (GFT505) is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways to treat nonalcoholic steatohepatitis (NASH).
Disease: NAFLD (non-alcoholic fatty liver disease) - NASH (non-alcoholic steatohepatitis)
Therapeutic area: Metabolic diseases - Liver diseases
Country:
Trial details:
Latest news: Genfit has announced the results of long-term animal toxicology studies involving up to two years of treatment. At the highest doses tested, GFT505 has no major adverse effect relevant to humans. In particular, none of the adverse effects previously observed in similar studies with the different classes of oral anti-diabetes drugs has been observed. In accordance with the regulatory requirements of official health agencies (FDA, ICH, and EMA) for the initiation of clinical trials involving more than 6 months of treatment, GFT505 has been tested in rats for 6 months at up to 100 mg/kg/day and in monkeys for one year at up to 50 mg/kg/day. At these high doses and in both species, GFT505 induced no toxic effect relevant to humans. In particular, GFT505 showed no adverse effect on cardiac function, in contrast to oral anti-diabetes drugs of the PPAR? class (glitazones and glitazars), that provoke cardiac hypertrophy and increase cardiac mortality at high doses in the same type of studies. Moreover, in contrast to PPAR? activators, long-term GFT505 treatment did not result in increased weight gain or edema. In parallel, and to further satisfy the regulatory requirements for long-term treatment, GFT505 has also been tested in rats and mice with daily administration for a period of two years. These complementary studies were designed to identify any potential carcinogenic risk of the product. Up to the highest dose tested, GFT505 did not show any carcinogenic effect relevant to humans. Again, the results contrast with those reported for certain oral anti-diabetes drugs in similar studies.
