Idenix-Phase 2B trial of IDX184 Reports Positive Interim Data

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Idenix Reports Positive Interim Data for Hepatitis C Drug

Idenix, which focuses on developing drugs to treat human viral diseases, said a Phase 2B trial of IDX184, the lead drug, found that the drug demonstrated potent antiviral activity in both preclinical and clinical studies.

Rapid virological response findings found that 73% of patients in the 100 mg IDX184 arm and 63% in the 50 mg arm had undetectable virus at 28 days. Currently, 87% of patients in the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a median of eight weeks of treatment.

"We are very pleased with the interim results for IDX184 and with the progress we made in 2011 across our programs," said Chief Executive Ron Renaud. "In 2012, we will build on this progress and believe we are well positioned to play a major role in treating HCV [hepatitis C virus] patients for the foreseeable future."...read more


Idenix Pharma's Hep C Drug Safe But Slow (And Ready For Sale)

SAN FRANCISCO (TheStreet) -- Idenix Pharmaceuticals experimental hepatitis C drug IDX184 looks to be safe (whew!) but doesn’t appear to work particularly fast (uh oh….)

On Monday morning, relief over the apparently clean safety report for IDX184 combined with a healthy dose of hepatitis C drug takeover speculation was all the fuel needed to send Idenix shares up $2.84, or 43%, to $10 in the pre-market session.

[Achillion Pharmaceuticals share, likewise, are up 35% to $10.65 on takeover speculation and positive data reported on its pipeline of hepatitis C drugs.]

Idenix's lead drug, IDX184, belongs to the same "nucleoside" or "nuc" class of oral Hep C drugs as Pharmasset'sPSI-7977 and Inhibitex's INX-189. Since both were acquired for huge premiums recently, popular thinking is that Idenix's turn at the M&A altar is imminent.

After 31 hepatitis C patients completed 28 days of treatment with IDX184 in combination with weekly interferon and ribavirin, no serious adverse events were reported and an independent safety monitoring board recommended that more patients can be enrolled in the phase II study, Idenix said Monday.

Based on this clean safety report, Idenix plans to ask U.S. regulators to remove a clinical hold on IDX184 put in place last year. The company reported the new IDX184 in advance of its presentation this afternoon at the J.P. Morgan Healthcare Conference.

Idenix said that 73% of patients treated with a 100 mg dose of IDX184 reported undetectable levels of the hepatitis C virus after 28 days. At a median treatment duration of 8 weeks in the study, 87% of these patients are now undetectable.

For patients treated with a lower, 50 mg dose of IDX184, 63% were undetectable at 28 days and 94% were undetectable at a median treatment duration of 8 weeks. None of these patients in the study have so far reported a re-emergence of the hepatitis C virus in their systems.

These efficacy data suggest that IDX184 works slower and perhaps is not as potent as the competing "nucs" being developed by Pharmasset and Inhibitex. For example, Pharmasset's PSI-7977 demonstrated a 4-week early response rate of 98% in a similar setting and patient population. Moreover, Idenix enrolled relatively healthier hepatitis C patients for this initial IDX184 study, suggesting that the drug may further underperform when hepatitis C patients with more advanced disease are treated.

"For us, this trial was about solidifying the safety profile of IDX184 as much as anything else. We believe we have demonstrated that and hope the FDA agrees with us. Our goal is to get to interferon-free regimens as soon as possible," said Idenix CEO Ron Renaud, in an email.

Renaud downplayed questions about the speed at which IDX184 can clear the hepatitis C virus, arguing that combinations of different types of oral drugs will likely be needed ultimately, but it's not clear yet what those combinations might be.

It's certainly true that big players in the race to develop an all-oral hepatitis C therapy -- Bristol-Myers Squibb, Gilead Sciences most prominently -- are betting on a "nuc" being the backbone of whatever regimen emerges. And right now, Idenix is sitting on a nuc -- IDX184 -- that appears safe and is certainly available to any interested bidder for the right price.

--Written by Adam Feuerstein in San Francisco.

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Idenix Reports Advancement of HCV Development Pipeline

-- Idenix advances HCV clinical development pipeline with initiation of phase I study of pan-genotypic NS5A inhibitor, IDX719

-- Idenix selects next-generation HCV nucleotide inhibitors, IDX19368 and IDX19370, to enter IND-enabling studies

-- Management to host conference call webcast at 5:30 a.m. PT/8:30 a.m. ET today

CAMBRIDGE, Mass. -- 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 advancement of its hepatitis C virus (HCV) development pipeline.

IDX719: NS5A Program

Idenix announced today the initiation of a phase I clinical trial of the Company's NS5A inhibitor, IDX719. The first part of the study will evaluate safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers. A subsequent part of the study will evaluate three days of IDX719 treatment in treatment-naïve genotype 1 HCV-infected patients and is expected to begin in the second quarter of 2012. Preclinical studies have shown that IDX719 has potent, pan-genotypic activity in vitro with the potential for once-daily dosing.

IDX19368 and IDX19370: Nucleotide Prodrug Program

Further, the Company has selected two additional nucleotide inhibitors, IDX19368 and IDX19370, as potential clinical candidates. The Company anticipates Investigational New Drug (IND) filings in mid-2012.

"Over the past year, Idenix has made significant progress in both our core nucleotide and NS5A programs," commented Ron Renaud, President and Chief Executive Officer of Idenix. "The preclinical profile of IDX719 is very competitive, and we are leveraging the Company's significant nucleotide chemistry expertise to discover novel nucleotides with promising properties as well as continuing to strengthen our IP position. We are excited about the potential of our novel antiviral compounds in the evolving HCV field in the coming year."

2011 Year-end Cash Balance

Idenix today reported that it ended 2011 with approximately $118.3 million of cash and cash equivalents. The Company's 2011 financial results have not yet been audited.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

CONFERENCE CALL AND WEBCAST INFORMATION

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 40631574. 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 January 23, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 40631574.

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