Print
Email
Print Edition Stories
The U.S. Food and Drug Administration has lifted a partial hold on a drug candidate developed by Cambridge-based Idenix Pharmaceuticals Inc. The hold related to a drug study of the company’s IDX184 and IDX320 programs to treat hepatitis C virus.
The FDA ordered the partial hold in September 2010 on Idenix’s lead product, IDX184, an oral nucleotide polymerase inhibitor, due to safety concerns of the drug interaction with IDX320, an investigational HCV protease inhibitor. The biotech said it notified the FDA after three healthy volunteers returned liver function abnormalities detected in post-exposure safety visits; the liver function tests in these patients have since returned to normal.
Idenix is testing IDX184 in a Phase 2b study on genotype 1 hepatitis C virus-infected patients, and it’s shown positive antiviral activity without any serious adverse effects, the company said in a news release.
Idenix (Nasdaq: IDIX) announced in November that it planned to raise about $61 million under a shelf registration.
Beyond its efforts in developing treatments for hepatitis C, the company has also developed treatments for hepatitis B virus and HIV/AIDS.
Comments
If you are commenting using a Facebook account, your profile information may be displayed with your comment depending on your privacy settings. By leaving the 'Post to Facebook' box selected, your comment will be published to your Facebook profile in addition to the space below.
RSS Feeds
