By Michael Fitzhugh
Idenix Pharmaceuticals (IDIX) halted a mid-stage study of two hepatitis C drugs after the U.S. Food and Drug Administration ordered it to suspend the trial over safety concerns. The news led investors to sink the company's shares on worries about the program's future.
Three healthy volunteers testing a combination of the drugs IDX184 and IDX320 showed elevated liver enzyme levels in a routine post-study safety test, the Cambridge, Massachusetts company says.
Although liver function returned to nearly normal levels in all three subjects, the FDA placed a clinical hold on the study until it can discuss the results and other relevant data with Idenix. The company is preparing that information now in hopes of expediting the agency's review and resolving the matter as quickly as possible. It says it is aiming for submission by the end of the year.
Idenix CEO and chairman Jean-Pierre Sommadossi says the company remains “committed to the future potential of these drug candidates,” based upon the safety and antiviral activity it has measured in other studies in which the drugs were tested alone, instead of in combination.
But investors chopped the value of Idenix shares nearly in half when news of the clinical hold hit. The price of Idenix shares fell to $3.18 from $5.99 on the day it was announced. On top of that punishment, the hold will also likely make Idenix's ongoing search for an outside partner to advance its hepatitis C program more difficult.
Idenix plans to present full data from studies of Idenix's IDX184, IDX320, and IDX375, the company's third experimental hepatitis C drug, at the annual meeting of the American Association for the Study of Liver Diseases in Boston at the end of October.
Hepatitis C treatment has been an active area for development this year. Bristol-Myers Squibb (BMY) moved to acquire ZymoGenetics, its partner on a promising mid-stage Hepatitis C drug, for $885 million in early September. Vertex Pharmaceuticals (VRTX) reported that telaprevir, its late-stage hepatitis C drug, can help some people tackle the virus in half the time the current treatment takes while minimizing side effects. There's also a GSK-Regulus Therapeutics partnership on miR-122, as well as a new drug application due from Merck (MRK) for its hepatitis C medicine boceprevir.
About 70 percent to 80 percent of the estimated 3.2 million people in the United States who have chronic hepatitis C virus infection don't know it because they are asymptomatic, according to the Centers for Disease Control and Prevention. But the disease can result in long-term health problems, including liver damage, liver failure, liver cancer, and even death.