IDX184-Idenix hepatitis C drug put on partial hold

.WSJ-The biopharmaceutical company in February said the FDA lifted a prior partial hold issued in September 2010 after three cases of elevated liver function tests were observed in the Phase 2B study.

Aug 16 (Reuters) - Idenix Pharmaceuticals Inc's experimental hepatitis C drug was placed on a partial hold by the U.S. health regulator, barely two weeks after Bristol-Myers Squibb Co's hepatitis C treatment encountered a heart-related safety issue.

Aug 24 Updated -
BMS halts the development of BMS-986094 due to patient death
The original patient subsequently died and eight others suffered from heart and kidney toxicity, the company said in a statement released last night. Two of the patients remain hospitalized.

Idenix shares dropped 24 percent in premarket trade.

 
The U.S. Food and Drug Administration wanted to further review its drug, called IDX184, citing the serious heart-related adverse event seen in a competitor's drug, Idenix said in a statement.

Idenix did not name the competitor but Idenix's IDX184 and Bristol's drug BMS-986094 were both being tested in mid-stage trials and both belong to a promising new class of hepatitis C medicines known as nucleotide polymerase inhibitors.

The FDA has requested additional data on patients treated with IDX184 and Idenix said in a statement it plans to have an ongoing discussion with the FDA following the data submission.

Nucleotide polymerase inhibitors work by targeting polymerase -- an enzyme essential for the replication of the hepatitis C virus -- and are expected to be the game changer for both patients and physicians.

Most hepatitis C drugs used today are combination therapies that include interferon. This causes unpleasant flu-like symptoms and other side effects, leading many patients to discontinue or delay treatment.

The new nucleotides, or nucs as they are commonly called, do not require the use of interferon.
The hepatitis C virus is the most common cause of viral hepatitis, an inflammation of the liver.

Idenix shares traded at $6.30 premarket after closing at $8.31 on Wednesday on the Nasdaq.

(Reporting by Esha Dey in Bangalore; Editing by Rodney Joyce)
((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: IDENIX FDA/HEPATITISC

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UPDATED: Idenix craters as clinical hold spurs tox jitters for hot hep C drug
August 16, 2012 | By John Carroll

Idenix Pharmaceuticals ($IDIX) went into free fall this morning, tumbling about 40% on the news that its nucleotide polymerase inhibitor IDX184 was put on partial clinical hold as the FDA studies whether a recent cardiac event that may well have spiked a similar treatment at Bristol-Myers Squibb ($BMY) raises similar toxicity issues for Idenix.

"In previous clinical trials as well as the ongoing Phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen with PegIFN/RBV alone," Idenix cautioned this morning in a short statement. But even a whiff of this kind of trouble is enough to spook investors who have bid up shares in hopes of cashing in on new treatments.

Cambridge, MA-based Idenix has been among the leaders in the mad scramble to advance new "nucs" and NS5A inhibitors that can be combined with ribavirin into an all-oral regimen with megamarket potential. But the quest for the new holy grail in biotech has been slowed by a cardiac event that has halted work on BMS-094. Analysts have pointed to a somewhat similar chemical structure between BMS-094--formerly INX-189 before Bristol bought Inhibitex in a $2.5 billion deal--and IDX184, which has sent shivers down investors' spines

Bernstein's Geoffrey Porges, though, think the differences outweigh the similarities of the two therapies. "This event is likely to raise concerns about the risks of nuke programs across the spectrum, but we believe it is important to understand the difference among the assets," he notes, according to Bloomberg.

Bristol-Myers hasn't written off its once-hot hep C drug, but it is pondering the move. Cardiovascular side effects have triggered the demise of many therapies and regulators have no tolerance for subjecting patients to potential risks in the clinic. Novartis ($NVS) recently relinquished its hep C partnership with Idenix, though most analysts have seen that as a positive move for the developer--at least until now.

- here's the press release
- here's the Bloomberg report
Read more
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Idenix held a conference to discuss IDX184's recent partial clinical hold
Idenix announced that the US FDA has put a partial hold on the phase II trial evaluating IDX184 for the treatment of hepatitis C.

The partial hold was in place due to the recent occurrence of a serious cardiac-related adverse event encountered with the company's competitor's nucleotide polymerase inhibitor for the treatment of HCV. Per the company, previous clinical trials conducted with IDX184, cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV was not beyond what was observed in patients treated with PegIFN/RBV alone.

Idenix said the company will work with the FDA to supply the Agency's requests for additional data on patients treated with IDX184. It plans to submit the data in the coming weeks.

IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine. The medication was developed using the company's proprietary liver-targeting technology which enables the delivery of nucleoside monophosphate to the liver. This will lead an increase in the formation of high levels of nucleoside triphosphate, maximizing the drug efficacy, and limiting systemic side effects with low, once-daily dosing.

The agent is currently being studied in the
phase II trial. The interim reports analyzing data from the first cohort of 31 patients showed:


10 patients achieved an extended rapid virologic response and completed an additional 12 weeks of PegIFN/RBV. 5 of these patients received 100 mg and 5 received 50 mg of IDX184 once daily.

100% patients in the 100 mg and 80% of patients in the 50 mg arm achieved a sustained virologic response four weeks after the study's completion.
.
The independent data safety monitoring board confirmed the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone in July 2012.

The company held a conference call which took place at 8:30 Eastern Time on 16-August-2012 to discuss the clinical hold.

Idenix will hold a conference call today at 8:30 a.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 22005490. A slide presentation will accompany the conference call and can be accessed on the Investor section of the Idenix website at www.idenix.com. Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.

A replay of the conference call and webcast will be available until August 27, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 22005490.

About Partial Clinical hold:

  • A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (IND) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, Idenix cannot enroll patients into additional clinical trials until agreement is reached with the FDA on the next clinical trial design


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