|Genfit's Dean Hum|
The French drugmaker Genfit will start a Phase II study in the coming months for its experimental liver damage drug elafibranor as it also hopes for a lull in the financial headwinds to get its IPO off this year.
The company--which is focusing primarily on studies to see if elafibranor can help nonalcoholic steatohepatitis (NASH) patients--said it was also seeking a license for the smaller primary biliary cholangitis (PBC) space, as it believes it can take market share from its competitors.
This includes U.S. biotech Intercept Pharmaceuticals ($ICPT), which is eagerly awaiting the outcome of an FDA panel--scheduled for next week--to decide whether it should approve its treatment for PBC. The condition causes damage to bile ducts that can inhibit the liver's ability to rid the body of toxins, and can lead to scarring of liver tissue.
This news comes after the small biotech announced earlier this month that it had raised €49.6 million ($53.9 million) in a private placement, giving it enough cash to reach 2018.
Both Genfit and Intercept are however betting big on bringing a new NASH drug to market to treat the fatty liver disease, which is estimated to affect as many as 5% of Americans. Its incidence is increasing as the condition is directly related to the growing rates of obesity and diabetes in the country.
Genfit already has elafibranor in Phase III studies for NASH and said it expects these trials to be completed by 2018, with a possible market entry in 2019. Like Intercept, however, it's also had a wobble in testing after its drug failed to beat a placebo in a mid-stage trial--but the company remains optimistic the drug is good enough for late-stage trials.
NASH currently has no approved treatments, creating a potential blockbuster market that has galvanized a major R&D push among biopharma companies.
Gilead Sciences ($GILD), Enanta Pharmaceuticals ($ENTA) and a host of other companies are also looking to advance NASH therapies of their own in a market that analysts think could be worth up to $40 billion, with individual treatments likely to take home an eye-watering $10 billion a year each.
The midstage trial of the daily pill for PBC will begin before the end of 2016 in patients that do not tolerate or do not respond sufficiently to the standard primary treatment with ursodeoxycholic acid--which occurs in around 70% of patients.
Dean Hum, the company's COO and CSA, told FierceBiotech it hopes to gain a sizable market share as, even though it will likely be second to market after Intercept, Hum said he believes the drug has a better side effect profile as it doesn't raise the "bad cholesterol" levels in patients (it has been shown to in fact lower LDL)--something he said has been seen in its competitors' data.
The company said it expected the drug to be approved by the FDA in 2019--the same year as it sees the green light being given for its NASH license. He did not offer the company's peak annual sales estimates for its PBC indication.
The company has made no secret of the fact that it wants a Nasdaq IPO, and Genfit said it was "still an important target for the company," but that the timing "was not opportune," given the ongoing headwinds hitting the industry. This has affected a number of biotechs going public this year, including the U.K.'s Shield Therapeutics and CA-based Corvus, which in recent months were both forced to take an IPO at a much reduced price than they initially wanted.
"We're in no huge rush, but we're prepared to wait for the best market conditions to get the IPO we want," he said. "That opportunity could be this year if things go well, but it might be next year if not. Partner discussions [with pharma for the drug] are also ongoing, so everything is moving forward and we are keeping out options open."
Genfit also announced its intention to launch new trials in NASH for pediatric as well as cirrhosis subpopulations.
- check out the release (PDF)