Dogged by questions over the safety of its approved liver drug Ocaliva and reeling from a rejection for the drug in fatty liver disease, Intercept Pharmaceuticals has been shedding its C-suite.
At the start of the year, Jerry Durso, the company's former chief operating officer, took over as chief from former CEO Mark Pruzanski, who remains on the board. Now, its chief medical officer, Jason Campagna, M.D., Ph.D., will be hitting the exit early next month.
The CEO change was not noted in a press release; instead, like much of its bad news, it was buried in a Securities and Exchange Commission (SEC) filing, which gave little information other than saying: “Dr. Campagna’s resignation was not the result of any disagreement regarding any matter related to the company’s operations, policies, or practices.”
It gave no reason for his departure nor mentioned whether he is taking up a role somewhere else. As the company looks to find a replacement, Gail Cawkwell, M.D., Ph.D., will serve as acting CMO.
This all comes amid a tough time for the company, though, a few years ago, things looked a lot brighter. Intercept is no pre-revenue biotech; it has a commercial asset in obeticholic acid, which is approved in primary biliary cholangitis (PBC) as Ocaliva, nabbing a U.S. green light back in 2016.
The big bucks, however, were set to come from it being the front-runner in the race to be the first drug approved to treat fatty liver disease, or nonalcoholic steatohepatitis (NASH), which could have yielded major annual blockbuster sales.
It has, however, stumbled on both fronts. For NASH, like so many other companies, Intercept has struggled to balance safety with efficacy. Last June, the FDA issued a complete response letter for the drug, saying the drug’s “predicted benefit … remains uncertain” and doesn’t warrant safety risks in patients with NASH-related liver fibrosis.
Intercept said regulators wanted longer-term data from its phase 3 trial to back the surrogate endpoint, i.e., a reduction in liver fibrosis (scarring), which entails more money and time. Not long after, Intercept unveiled plans to trim 25% of its headcount, or about 170 jobs.
And while getting approval for Ocaliva in PBC looked like an early win that set the path for NASH, it’s having issues there, too. Last year, again quietly announced via a SEC filing, the company said the FDA was reviewing the drug for causing a “potential liver disorder” that poses a possible risk. That review is still ongoing, though it already has a black box warning issued back in 2018.