Reuters Health Information: Genfit plans to test its drug in second liver disease
Genfit plans to test its drug in second liver disease
Last Updated: 2016-03-31
By Bill Berkrot
NEW YORK (Reuters) - French drugmaker Genfit SA on Thursday
said it would begin a midstage trial this year of its
experimental drug elafibranor to treat primary biliary
cholangitis, a chronic disease in which bile ducts in the liver
are gradually destroyed.
The company is already enrolling a 2,000-patient Phase III
trial of elafibranor for nonalcoholic steatohepatitis (NASH),
which is driven by obesity, diabetes and over-indulgent
lifestyles and can lead to cirrhosis, liver failure and cancer.
Genfit expects the late-stage trial for NASH to be completed
by mid-2018 with possible approval a year later in a market some
analysts have said could grow to as much as $40 billion, with
effective drugs racking up annual sales of $10 billion each.
"We think we can take 50 percent of the (NASH) market,"
Genfit Chief Executive Jean-Francois Mouney told Reuters.
Mouney said Genfit decided to also go after the far smaller
primary biliary cholangitis (PBC) market because it believes its
drug offers advantages over treatments from likely competitors,
such as Intercept Pharmaceuticals Inc, and because most patients
are not helped by current treatments.
The damage from PBC can inhibit the liver's ability to rid
the body of toxins, and can lead to cirrhosis.
In earlier trials, the Genfit drug led to reductions in LDL
cholesterol, triglycerides and blood sugar. Some potential rival
drugs have caused LDL increases in clinical trials.
A panel of advisers to the U.S. Food and Drug Administration
is scheduled next week to decide whether to recommend approval
of Intercept's drug for PBC.
The Genfit PBC trial will test its one pill, once-a-day drug
in patients who do not tolerate or do not respond sufficiently
to the current standard treatment with ursodeoxycholic acid.
That can be as many as 70 percent of PBC patients, Genfit said.
After discussions with experts in the field, we have decided
"that PBC is the next logical target in our development plan,"
Mouney said in a statement.
The company made the announcement at a meeting in New York
to discuss its research and development plans.
Genfit said it will work with regulatory agencies to
determine the study goals and design in the coming months, with
the aim of beginning the trial before the end of the year.