Idenix Pharmaceuticals Inc. shares fell Monday after the company said the Food and Drug Administration is halting development of another one of its hepatitis C drugs.
Idenix said the FDA is barring it from testing a drug called IDX19368 on humans. The Waltham, Mass., company recently filed for approval to test the drug on people and hoped to begin those trials during the third quarter. The FDA has halted studies of two Idenix drugs because of concerns they could damage patients’ hearts, and the agency wants Idenix to conduct additional testing to evaluate the cardiovascular effects of one of the drugs.
Shares of Idenix lost 19 cents, or 3.2 percent, to $5.82 in morning trading.
On Aug. 1, competitor Bristol-Myers Squibb Co. said it was stopping a clinical trial of a hepatitis C drug called BMS-986094. The company reported that one patient in a clinical trial died of heart failure following treatment. On Friday Bristol-Myers said it is abandoning development of the product and taking a $1.8 billion charge in the third quarter to write down its value. Less than six months earlier, Bristol-Myers paid $2.5 billion to buy Inhibitex, the company that developed the drug.
The Bristol-Myers drug and the two Idenix drugs, IDX184 and IDX19368, work in similar ways. All three products are nucleotide inhibitors, meaning they are designed to prevent the hepatitis C virus from making copies of itself. Idenix said Monday that there are also important differences between the drugs. It also said a few patients from the current trial of IDX184 have already had echocardiograms and the results are normal.
The FDA placed IDX184 on clinical hold Aug. 16. Idenix said it has scheduled scans for about 50 patients from a mid-stage trial of that drug, and it will submit the results to the FDA within a few weeks. The Cambridge, Mass., company said Bristol-Myers will share information from its clinical trials and it hopes to resolve the FDA’s concerns quickly.
“Based on our discussions with the FDA, we understand the clinical hold is a precautionary decision made by the FDA in light of the adverse events seen with BMS-986094,” said Idenix President and CEO Ron Renaud.
IDX184 is Idenix’s most advanced experimental drug. The company is running clinical trials of one other hepatitis C drug and is developing several others.