Clinical Trials

Date: 2018-08-28

Type of information: Completion of patient enrollment

phase: 2

Announcement: completion of patient enrollment

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).

Disease: primary biliary cholangitis (PBC)

Therapeutic area: Liver diseases - Hepatic diseases

Country:

Trial details:

• This Phase 2a trial is evaluating elafibranor in primary biliary cholangitis. The trial is designed to be a multicenter, double-blind, randomized, placebo-controlled, study to evaluate the efficacy and safety of elafibranor in adult patients with PBC and inadequateresponse to ursodeoxycholic acid (UDCA). The trial is designed as follows: - 3 arms (80mg, 120mg, placebo) - 45 patients (15 patients per arm) - 12 weeks treatment - Clinical centers in the U.S. and in 3 European countries The primary objective is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase (ALP) in these patients, based on relative change from baseline to end of treatment compared to placebo. Secondary endpoints include: - ALP < 1.67 × upper limit of normal (ULN) and total bilirubin within normal limit and > 15% decrease in ALP - Paris, Toronto, UK PBC scores - Pruritus and QoL (Quality of Life) - Safety of elafibranor in a PBC population

Latest news:

• • On August 28, 2018, Genfit announced the completion of enrolment in the Phase 2a trial evaluating elafibranor in PBC (Primary Biliary Cholangitis). The company anticipates the release of top line data by end-of-year. The 45th (and last) patient was enrolled in July, and a number of patients have already finished the 12-week treatment period.
• • On May 5, 2017, Genfit announced that the first patient has been enrolled in the Phase 2a trial is evaluating elafibranor in primary biliary cholangitis
• • On September 27, 2016, Genfit announced that it is filing an IND submission for a Phase 2 trial in primary biliary cholangitis (PBC), aimed at evaluating decrease in alkaline phosphatase (ALP) with elafibranor vs placebo. This trial is designed to be a multicenter, double-blind, randomized, placebo-controlled, phase 2 study to evaluate the efficacy and safety of elafibranor after 12 weeks of treatment in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid. The primary objective is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase (ALP) in these patients, based on relative change versus placebo. Secondary endpoints will include:  ALP < 1.67 × upper limit of normal (ULN) and total bilirubin within normal limit and > 15% decrease in ALP ; Paris, Toronto, UK PBC scores ; Pruritus and QoL (Quality of Life) ; Safety of elafibranor in a primary biliary cholangitis population.
• • On March 31, 2016, Genfit announced at the GENFIT R&D Event in New York City, that the Company plans to begin a second elafibranor clinical program in 2016, targeting unmet need in the liver disease Primary Biliary Cholangitis (PBC). The company intends to begin a Phase 2 clinical trial of elafibranor in the treatment of PBC before the end of 2016, in patients that do not tolerate or do not respond sufficiently to the standard primary treatment, with ursodeoxycholic acid (UDCA), which may occur in approximately 70% of patients. The Company will work with regulatory agencies to confirm the most appropriate trial endpoints and study design in the coming months. Genfit also announced its intention to launch new trials in NASH for pediatric as well as cirrhosis subpopulations.

Is general: Yes