Genfit throws in the towel on NASH, exiting a tumultuous field full of bright market prospects and lethal R&D setbacks
Genfit has had enough of NASH.
The French biotech $GNFT says it’s looked at its failed Phase III from every angle, and sees no need to keep pushing on elafibranor for NASH resolution without worsening fibrosis. They’re now shutting down RESOLVE-IT, but they’ll keep working on the drug, focusing entirely on Primary Biliary Cholangitis (PBC) while continuing with its NASH diagnostic tool NIS4.
In announcing disappointing results 2 months ago in a comparison with a placebo, Genfit execs offered that they believed the placebo response was high at 14.7%, but there clearly was no road ahead for a drug with a meager 19.2% response rate.
The biotech billed today’s announcement as the “first step” of the new corporate strategy, allowing the company to accelerate its cost-saving plan.
NASH overall has been a disaster zone for drug developers. Lured in by the prospect of a massive market, the leading players have been blitzed by failures. That trend was highlighted just 4 weeks ago, when Intercept bitterly reported the FDA’s rejection of their application for OCA.
The biotech reported that the rejection was spurred by regulators’ uncertainty about their surrogate endpoint on a reduction in liver fibrosis, uncertain with how that would ultimately play out for patients.
Intercept saw it as the culmination of a fickle change of stance on the FDA’s part.
Genfit’s exit after years of travails leaves one less player as investors inevitably recalculate the amount of risk involved in drug R&D in NASH. Now the biotech will push for a comeback with its share price crippled by NASH.