French biotech Genfit, a leader in the race to sell a new med for fatty liver disease, said in its financials that it will delay its phase 3 NASH trial in patients with liver scarring by four to six months.
In its first-quarter update, Genfit said that the RESOLVE-IT late-stage test of its once-daily NASH candidate elafibranor would not see the first 1,000 patients enrolled until the first quarter of next year.
“While enrollment of patients with F1 [early] fibrosis stage is in advance of expectations, patients with F2 and F3 [later] fibrosis stages follow a more moderate enrollment curve compared to the initial projections,” the biotech said in its update.
The pivotal phase 3 study RESOLVE-IT, which started enrollment just over a year ago, is set up to “achieve conditional marketing approval” based on the interim analysis of the first 1,000 patients, after 72 weeks’ treatment, based on a single histological surrogate endpoint.
The complete test is a double-blind, placebo-controlled study conducted in around 2,000 patients at 250 centers worldwide, with elafibranor 120 mg or placebo given every day.
This biotech says: “This change of four to six months from the current timeline is partly due to the increasing number of clinical trials now being launched in NASH, but is mainly attributable to the company's desire to ensure enrollment quality so as to produce the most statistically robust clinical trial by ensuring that patient stratification ratios remain as close as possible to the medical reality.”
It said that, based on “past experience,” it is paying “close attention” to the following factors:
- Ethnically balanced enrollment, even if the diversity sought creates administrative delays, particularly in certain countries in South America;
- Balance between the two arms of the study in each study center, leading to the selection of those centers which are able to mobilize a sufficiently large number of potentially eligible patients;
- Balance within the randomized patient population (gender, disease severity) and among geographical regions of enrollment.
Genfit stressed that this change “has no significant impact on the main goal for elafibranor to be prescribed as a first-line treatment in NASH and to constitute a cornerstone in combination therapy.” It has previously said it saw a market entry for its med by 2019, but did not say whether this had now been changed.
It added that more centers will be opened to “limit deviations from the initial timeline.”
Last year, the small biotech said it had raised €49.6 million ($53.9 million) in a private placement, giving it enough cash to reach 2018.
It’s not been all smooth sailing in previous trials, and it had a wobble in testing after its drug failed to beat placebo in a mid-stage study a few years back. But the company remains optimistic the drug can deliver the goods in a late-stage trial.
It will need to as it races a rival pack made up of Intercept, Gilead, Shire, Novartis, Allergan and others to create a market that could be worth billions.
The biotech, listed on the EPA, was down 1.8% late morning European time.