French biotech Genfit has pressed the button on a public listing in the US, seeking to raise around $120m to help it fund development of lead liver disease drug elafibranor.
Genfit is offering five million shares at $26.33 on the Nasdaq Global Market to raise the cash, with the US listing sitting alongside the biotech’s current shares on the Euronext Paris exchange.
Around $50m of the proceeds will be used to complete a phase 3 trial of elafibranor in non-alcoholic steatohepatitis (NASH) – a hot therapeutic target in biopharma at the moment with no approved therapies – with another $15m earmarked to build the company’s commercial operations in anticipation of a launch.
$35m has been allocated to a phase 3 trial of elafibranor in primary biliary cholangitis (PBC), a rare autoimmune disease of the liver, and $6m will go towards developing a companion diagnostic for NASH to identify patients suitable for treatment with its drug, with another $6m set aside for testing the drug in combination regimens.
Elafibranor is a dual agonist of the peroxisome proliferator-activated receptor (PPAR) alpha and delta receptors, thought to play a key role in various metabolic processes that lead to the lipid changes, fibrosis and inflammation that characterise NASH.
In an SEC filing, the French company says that in a phase 2b trial elafibranor “achieved resolution of NASH without worsening of fibrosis, which is the primary endpoint of our ongoing global phase 3 clinical trial”.
It is expecting to have interim results from the pivotal trial before the end of the year and, if positive, thinks these will support accelerated approvals from the FDA and EMA. Elafibranor as already been granted a breakthrough designation from the US regulator in NASH, setting up a speedy review of the application if filed.
In December Genfit also reported positive phase 2 data with the drug in PBC, which has two approved therapies that according to the company are plagued by safety and efficacy issues. A phase 3 PBC trial is scheduled to start before the end of 2019.
Dozens of treatments are coming through the biopharma industry pipeline for NASH, which causes fatty build-up and fibrosis in the liver, in serious cases leading to cirrhosis and the need for a liver transplant. With millions of patients on the NASH spectrum worldwide, some estimates put the market potential at more than $20bn, promising rich rewards for the first companies to get drug treatments approved.
Last month, Gilead Sciences’ plans in NASH suffered a setback when its lead candidate selonsertib, an ASK1 inhibitor, missed the mark in its first phase 3 trial, albeit one in a hard-to-treat patient group.
Shortly afterwards, Intercept Pharma reported somewhat mixed phase 3 data for its NASH drug obeticholic acid, although analysts suggested the data could still be enough to support an FDA approval. The study showed that the drug was able to improve liver fibrosis compared to placebo.