Date: 2016-03-10
Type of
information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Genfit (France)
Product: elafibranor - 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). Elafibranor is believed to address mutliple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic
area: Metabolic diseases - Liver diseases
Country: Belgium
Trial
details: RESOLVE-IT is a randomized, double-blind, placebo-controlled (2:1) Phase 3 clinical trial targeting approximatively 2,000 patients, and involving about 200 centers worldwide. The study population includes NASH patients (NAS?4) with F2 or F3 fibrosis who will be administered Elafibranor 120mg or placebo once daily. Analysis, targeting initial regulatory application under Subpart H, will be performed after 72 weeks of treatment on the first ~1,000 patients, evaluating the effect of Elafibranor based on the following surrogate histological primary endpoint (with centralized histological reading): NASH resolution (corresponding to ballooning=0, inflammation=0-1) without worsening of the fibrosis. In order to measure the long-term clinical benefit of NASH resolution induced by Elafibranor 120mg, the trial will continue on a blinded-basis following the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis and other liver related events.(NCT02704403)
Latest
news:
- • On March 10, 2016, Genfit announced that it has enrolled the first patient in its Phase 3 clinical trial RESOLVE-IT, evaluating elafibranor as a treatment against NASH.
• On November 16, 2015, Genfit announced the design of the global phase 3 trial to evaluate the benefits of Elafibranor treatment on NASH patients. The pivotal trial will be a randomized, double-blind, placebo-controlled (2:1) Phase 3 trial, conducted in approximately 1800 patients, at 200 centers worldwide. The study population will include NASH patients (NAS?4) with F2 or F3 fibrosis. Elafibranor 120 mg and placebo will be administered once daily. An interim analysis, for initial market approval under Subpart H, will be performed after 72 weeks in order to evaluate the beneficial effect of Elafibranor on the liver histology of the first 900 patients. To support full approval, the trial will continue in order to demonstrate the impact of Elafibranor on the prevention of cirrhosis and other liver related outcomes on the full study population. A group of patients with F1 fibrosis and concomitant cardiometabolic comordities, which are associated with rapid progression of the disease, will also be enrolled.
Initial approval will be based on the interim analysis (72 weeks / 900 patients) of the following surrogate histological primary endpoint : NASH resolution without worsening of the fibrosis, corresponding to ballooning=0, inflammation=0-1. This criteria defining disease activity, and based on a centralized histological reading, is considered by the regulatory authorities as well as NASH experts as a surrogate endpoint for approval.
In order to confirm the long-term clinical benefits of NASH resolution induced by Elafibranor 120mg, the trial will continue post-marketing and remain blinded after the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis and other liver related events.
The trial will evaluate key secondary histological endpoints, including an improvement on fibrosis, and non-invasive markers of steatohepatitis. In addition, the trial will assess the improvement of cardiometabolic profile,
including plasma lipids, glucose homeostasis and inflammatory markers. The trial initiation is anticipated in fourth quarter of 2015.
Is
general: Yes
