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Idenix sees delay in human trials for hep C drug as FDA seeks more data
  Fri Jun 21, 2013 4:17am IST
Idenix Pharmaceuticals ($IDIX) has encountered a roadblock in the race to develop oral drugs for hepatitis C virus. The FDA has hit the biotech group with a request for more preclinical data on IDX20963, which is Idenix's lead drug in the closely watched class of uridine nucleotide prodrugs, sometimes called "nucs" for short.
(Reuters) - Idenix Pharmaceuticals Inc said it expects a delay in human trials of one of its experimental hepatitis C drugs after the U.S. Food and Drug Administration asked for additional safety data, sending its shares down 21 percent after the bell.
Clinical trials of the drug, codenamed IDX20963, has been put on hold until it provides a satisfactory response to the FDA, Idenix said in a statement. Hepatitis C is an disease that affects the liver and if left untreated can lead to cirrhosis, cancer or need for a transplant.
In early February, the company stopped the development of two other hepatitis C drugs, IDX184 and IDX19368, after the FDA continued with a clinical hold, initiated following the death of a patient in a mid-stage trial conducted by Bristol-Myers Squibb Co using a similar compound.
"This signifies that the preclinical/clinical development of any nuc is likely even more challenging than anticipated," Oppenheimer & Co analyst David Ferreiro said in a note.
Idenix's hepatitis C drugs have been developed using a technology called polymerase inhibitors, or nucs. Nucs prevent the virus from multiplying and represent a new class of drugs for the disease.
IDX20963 belongs to a sub-class of nucs called uridine nucleotide, and the company has said previously that it is distinct from the two drugs whose development was stopped.
Ferreiro also noted that this setback occurred even when the drug -- a uridine analog is deemed safer than other nucs.
"Consequently, we continue to hold low expectations for IDX20963's ultimate success," he said.
Idenix shares were down at $4.03 in after-market trading. They closed at $5.13 on the Nasdaq on Thursday.
June 20, 2013
Idenix Pharmaceuticals Announces Update on Development Program for Its Lead HCV Nucleotide Prodrug Candidate, IDX20963
Idenix Pharmaceuticals Announces Update on Development Program for Its Lead HCV Nucleotide Prodrug Candidate, IDX20963
CAMBRIDGE, Mass., June 20, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the Company has received verbal communication from the U.S. Food and Drug Administration (FDA) requesting additional preclinical safety information for IDX20963, Idenix's lead uridine nucleotide prodrug candidate. Initiation of clinical trials for IDX20963 is on hold and the Company must provide a satisfactory response to the FDA before clinical trials can begin in the United States. As a result, the Company anticipates a delay in the initiation of the clinical program for IDX20963 while it responds to the FDA's comments. Idenix recently submitted an Investigational New Drug (IND) application for IDX20963 to the FDA, including preclinical data demonstrating potent, pan-genotypic activity.
CONTACT: Idenix Pharmaceuticals
Teri Dahlman, (617) 995-9807
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