A Boston-based biotech company has announced it will stop work on two promising hepatitis C drugs. Idenix Pharmaceuticals made the announcement after receiving word from federal regulators that the two medications would remain on clinical hold because they were suspected of causing serious complications.
The drugs - IDX184 and IDX19368 - were placed on hold by the U.S. Food and Drug Administration (FDA) in August 2012, after problems arose with a similar drug manufactured by Bristol Myers Squibb. Apparently, a patient participating in a clinical trial of the Bristol Myers Squibb drug BMS-986094 died of heart failure following treatment. There were also concerns about kidney issues arising among those who took the medicine.
Both companies' drugs are nucleotide polymerase inhibitors and are created from the same set of compounds, called guanosines. According to Bloomberg News, the medications are designed to prevent the virus from replicating itself. The pills were believed to provide shorter treatment durations and fewer side effects than those that are currently available.
"Although we are choosing not to continue our IDX184 and IDX19368 programs, we intend to maintain our strong presence in developing nucleotide polymerase inhibitors for [hepatitis C] based on our broad discovery platform," said Ron Renaud, Idenix's president and chief executive officer.
Idenix officials said they did not find any evidence of the drugs causing severe cardiac side effects. However, after submitting the information to the FDA, regulators said distribution of the medications would remain on hold.
Hepatitis C is a contagious liver virus that is spread through infected blood. According to the U.S. Centers for Disease Control and Prevention, it can also be transmitted through sexual contact, especially among those who have multiple sexual partners.
It's estimated that more than 3 million Americans are living with the virus, although many don't know they have it. Symptoms can be mild and include fever, fatigue, loss of appetite, nausea, abdominal pain and yellowing of the skin. However, it is a serious disease that can lead to long-term health problems including liver failure.