FASST Phase IIb Trial
We are currently investigating lanifibranor in the Phase IIb randomized, double-blind, placebo-controlled FASST (For A Systemic Sclerosis Treatment) clinical trial for the treatment of patients with dcSSc.
The primary endpoint of the trial is a mean change from baseline in skin thickness.
The mRSS is a clinically validated and FDA-accepted endpoint measuring the evolution of skin fibrosis, and skin fibrosis is known to be correlated with internal organ fibrosis.
We completed enrolment of 145 patients in October 2017.
The trial is being conducted at 47 sites in Europe. Patients were randomized to receive either lanifibranor at a dose of 400mg or 600mg twice daily or placebo, at a ratio of 1:1:1, for a period of 48 weeks.
NATIVE Phase IIb Trial
We are currently investigating lanifibranor in the Phase IIb randomized, double-blind, placebo-controlled NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial for the treatment of patients with NASH. The goal of the trial is to assess improvement in liver inflammation and ballooning, which are two of the markers of the resolution of NASH.
The primary endpoint of the trial is a reduction in the combined inflammation and ballooning score of two points compared to baseline, without worsening fibrosis. The scoring of this endpoint is performed in a centralized laboratory following liver biopsy and using the steatosis, activity and fibrosis, or SAF, score, which is a commonly accepted, semi quantitative evaluation of liver biopsy results.
We plan to enrol 225 patients with NASH at more than 80 sites in Europe, the United States, Canada, Australia and Mauritius.
iMProveS Phase IIa Trial
We are currently investigating odiparcil in the iMProveS (improve MPS treatment) Phase IIa clinical trial for the treatment of adult patients with MPS VI.
The trial is being conducted at two sites in Europe. The primary endpoint of the trial is safety, as assessed by clinical and biological standard tests.
We plan to enrol 18 adult MPS VI patients receiving enzyme replacement therapy (ERT) who will be randomized to receive odiparcil at a dose of either 250mg or 500mg twice daily or placebo for a period of 26 weeks, with a 10-week follow-up period. We also plan to enrol six patients not receiving ERT in an open-label cohort, who will receive 500mg of odiparcil twice daily.
In the first half of 2019, we also plan to begin sequential enrolment of nine children in a randomized, double-blind, placebo-controlled Phase Ib clinical trial with odiparcil (SAFE-KIDDS, SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study).