NASH and an $135 Million IPO: An Interview With Genfit's Dean Hum
GENFIT, with offices in Lille, France and Cambridge, Mass., launched its initial public offering (IPO) on the Nasdaq on March 27. The company, which focuses on liver diseases, with nonalcoholic steatohepatitis (NASH) a primary focus, offered 6,150,000 ordinary shares at a price of $20.32 with a concurrent private placement of 500,000 ordinary shares in Europe and other countries outside the U.S. at an offering price of 18 euros per ordinary share. The total funds the company raised is $135.1 million. The shares are trading on the Nasdaq under the GNFT symbol.
The company’s lead compound is elafibranor, which is currently in the RESOLVE-IT Phase III clinical trial for NASH. NASH is a disease similar to cirrhosis of the liver, but occurs in people who drink little or no alcohol. A buildup of fat in the liver results in inflammation, causing fibrosis, which can lead to liver failure. It is related to the obesity and type 2 diabetes epidemics, and aside from lifestyle changes, there is no currently approved drug for the disease.
Dean Hum, chief operating officer of Genfit, took time out to speak with BioSpace about the company, the IPO and elafibranor.
Genfit, Hum says, focuses on metabolic diseases, which is how it got involved in the field of NASH. “I think the other important aspect is the particular focus and expertise we have in nuclear receptors,” he said. “Our scientific founder, Bart Staels, is really an expert on nuclear receptors, especially PPAR, especially PPARa and PPARd.”
The company’s lead compound is elafibranor, which came out of the company’s internal research efforts, wholly discovered and developed within the Genfit team.
Although a French company, and also listed on Euronext Paris, Hum indicates that the Nasdaq listing is important, but so is its presence in the U.S. “We do have a strong footprint in the U.S., we have part of the development team in Cambridge, Mass. We also have corporate strategy and investor relations, and part of the commercialization team in the Boston office as well. It’s important to access expertise as well as well-experienced people to join the Genfit team. The team we have is very experienced with a lot of talent and we want to continue to build upon that.”
And Genfit is not a one-trick pony. In addition to elafibranor, it has nitazoxanide in Phase II trials for fibrotic diseases that could also be used as a combination with elafibranor. There is also another program, TGFTX1 that is targeting autoimmune diseases, such as psoriasis, asthma and COPD.
Perhaps more importantly, it developed an in vitro diagnostic test for NASH. Many NASH patients are asymptomatic. Definitive diagnosis is through an invasive liver biopsy. But this new diagnostic test is on a blood sample. Genfit inked a licensing deal with LabCorp and its Covance division to develop and commercialize the test for the clinical research market.
Hum notes, “If you want patients to benefit from the drugs on the market, you need to identify them. This is why the whole NASH field is going to be important to an in vitro diagnostics approach. We have a blood test that is able to identify NASH patients for therapy. It can be used to find those patients who should be considered for drug therapy and once the diagnosis is confirmed, doctors can decide which drug to use.”
In December, Genfit announced a readout of its Phase II trial of elafibranor in patients with primary biliary cholangitis (PBC), a chronic liver disease. The drug met all its primary endpoints. Hum says they’re also moving forward with other programs for the drug, including in the pediatric NASH population, children and adolescents, which make up about 3 percent of the NASH population. They are also moving forward in PBC and, of course, the ongoing Phase III trial in NASH. That trial, he said, “is fully recruited and we are in line to read out topline results by the end of the year.”
There currently are other big competitors trying to get drugs for NASH onto the market. One is Gilead Sciences. However, in February, the company’s selonsertib failed to meet the primary endpoint in its STELLAR-4 Phase III clinical trial in NASH. Another is Intercept Pharmaceuticals. On February 19, the company announced positive results from its Phase III REGENERATE trial of obeticholic acid (OCA) in patients with liver fibrosis caused by NASH. Intercept has generally been viewed as being the company most likely to get a NASH drug on the market, and that’s probably still the case, although if all goes well, Genfit’s elafibranor won’t be far behind.
Hum told BioSpace, “With that in mind, elafibranor, in Phase II, showed we could potentially resolve NASH without the worsening of fibrosis. That hits on the endpoint used in Phase III by the FDA for drug registration. We showed in our Phase II that elafibranor decreases cardiovascular factors. We’ve shown this consistently throughout our Phase IIa in different populations and in Phase IIb in NASH patients. The reason that’s important is the leading cause of mortality in NASH patients is cardiovascular events and most NASH patients have increased cardiovascular risk.”
So when elafibranor hits the market, it’s going to be the only drug that’s able to resolve NASH combined with a decrease in cardiovascular risk factors. In addition, the drug has shown no safety issues, no toxicology issues or tolerability issues. Hum says, “If you figure NASH patients will be treated long-term and are usually asymptomatic, you believe the clean safety profile and tolerability is going to be very important. That’s why we think elafibranor is strongly positioned to be used as a first-line therapy as a monotherapy and as a background for a combination therapeutic, which is likely the way the whole field will go to manage the NASH population.”