EASL; INX-189 Positive Safety/Antiviral Data from Phase 1b Hepatitis C Study

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EASL; INX-189 Positive Safety/Antiviral Data from Phase 1b Hepatitis C Study

Inhibitex Reports Positive Safety and Antiviral Data from Its Phase 1b Study of HCV Nucleotide Inhibitor INX-189Potent Dose-Dependent Antiviral Activity Demonstrated with Once-Daily Administration--Viral Load Declines in Combination with Ribavirin Confirm Antiviral Synergy-ATLANTA--(BUSINESS WIRE)--Mar 31, 2011 - Inhibitex, Inc.(Nasdaq: INHX) today reported positive top-line safety andantiviral data from its multiple ascending dose Phase 1b clinicaltrial of INX-189, an oral nucleotide polymerase inhibitor beingdeveloped to treat chronic infections caused by hepatitis C virus(HCV). The trial was a double-blind, placebo-controlled, doseescalation study designed to evaluate the safety, tolerability,pharmacokinetics and antiviral activity of INX-189, administeredorally once-daily

for seven days, in HCV genotype 1 treatmentnaïve patients. A total of 70 subjects were randomized intothe trial among seven different dosing cohorts, including fivemonotherapy treatment arms and two arms of adjunctive treatmentwith ribavirin (RBV). Each treatment cohort in the study wascomprised of 10 patients, eight of whom received INX-189 and twothat received placebo.INX-189, dosed once-daily at 9, 25, 50 and 100 mg for sevendays, demonstrated potent and dose-dependent antiviral activitywith median HCV RNA reductions from baseline of -0.64, -1.00,-1.47, and -2.53 log10 IU/mL, respectively. INX-189,dosed once-daily at 50 mg for one day, followed by 9 mg for sixdays, achieved a median HCV RNA reduction from baseline of -0.50log10 IU/mL. The median HCV RNA decline from baselineobserved in patients that received placebo was -0.20log10 IU/mL. INX-189, dosed

once-daily in combinationwith RBV for seven days at 9 mg and 25 mg, resulted in median HCVRNA reductions from baseline of -0.75 and -1.56 log10IU/mL, respectively. The median HCV RNA decline from baselineobserved in patients that received placebo and RBV was 0.04log10 IU/mL.

Cohort(INX-189 QD)

Median HCV log10 IU/mL RNAViral Load Decline after 3 doses

Median HCV log10 IU/mL RNAViral Load Decline after 7 doses

Range Day 7HCV log10 IU/mL RNA

Placebo(n=10)

0.25

-0.20

0.60 to-0.30

9 mg(n=7)

-0.29

-0.64

-0.19 to-1.06

25 mg(n=8)

-0.85

-1.00

-0.56 to-1.58

50 mg(n=8)

-1.34

-1.47

-1.17 to-2.30

100 mg(n=8)

-1.46

-2.53

-1.35 to-2.78

50 mg x 1 day9 mg x 6 days(n=7)

-0.46

-0.50

0.11 to-0.88

RBV withPlacebo(n=4)

-0.13

0.04

1.47 to-0.61

9 mgwith RBV(n=7)

-0.45

-0.75

-0.35 to-0.93

25 mgwith RBV(n=8)

-1.35

-1.56

-0.77 to-2.68

In addition to these median reductions in viral load, clinicallymeaningful decreases in alanine transaminase (ALT) levels wereobserved for patients receiving INX-189 at all dose levels, and nopatients experienced viral breakthrough.Additional data available from the Phase 1b study indicate thatINX-189 was generally well tolerated. There was one serious adverseevent reported in a subject treated with RBV and placebo (atrialfibrillation in a subject with a previous history). All otherreported adverse events were mild or moderate, with the most commonadverse event in INX-189 treated subjects being headache. Therewere no discontinuations of treatment due to adverse events andthere were no adverse events related to changes in clinicallaboratory evaluations or ECGs.“Nucleotide polymerase inhibitors are likely to be a keycomponent of combination direct antiviral therapy,†statedDr.

Lawitz, President and Medical Director at Alamo MedicalResearch, San , Texas and a principal investigator of thePhase 1b study. “Further, the antiviral activity observed atthe low INX-189 doses evaluated is promising, provides proof ofconcept, and provides the foundation for future studies.â€â€œThe potent antiviral activity in monotherapy and thesynergistic activity observed in combination with RBV support ourbelief that INX-189 has the potential to play a pivotal role infuture HCV combination therapy,†commented ph M. Patti,Ph.D., Inhibitex's CSO and Senior Vice-President of Research.“We believe these data, taken together with the successfulcompletion of our 13-week GLP toxicology studies, support advancingINX-189 into Phase 2 clinical trials later this year.â€About HCV and INX-189Hepatitis C is a disease of the liver caused by HCV. It isestimated that over 4

million Americans and 170 million individualsworldwide are infected with HCV, the majority of which representchronic infections that can cause liver disease, cirrhosis andcancer, and is the leading cause of liver transplants in the UnitedStates.Inhibitex is developing a series of proprietary nucleotideinhibitors that target the RNA-dependent RNA polymerase (NS5b) ofHCV. INX-189 is a protide of a 2'-C-methyl guanosineanalogue. The Company believes that preclinical and clinicalstudies of INX-189 completed to-date support its potential as apotent, once-daily, low dose oral therapy amenable to combinationwith other antivirals for the treatment of patients with all knowngenotypes of HCV.About InhibitexInhibitex, Inc. is a clinical stage biopharmaceutical companyfocused on developing products to prevent and treat seriousinfectious diseases. In addition to INX-189, the Company's

clinicalstage pipeline includes FV-100, a bicyclic nucleoside inhibitor inPhase 2 development for the treatment of shingles. The Company alsohas additional HCV nucleotide polymerase inhibitors in variousstages of preclinical development, and has licensed the use of itsproprietary MSCRAMM® protein platform to Pfizer forthe development of active staphylococcal vaccines. For additionalinformation about the Company, please visit www.inhibitex.com.Safe Harbor StatementThis press release contains forward-looking statements withinthe meaning of the Private Securities Litigation Reform Act of 1995that involve substantial risks and uncertainties. All statements,other than historical facts included in this press release,including statements regarding: the likelihood of nucleotidepolymerase

inhibitors being a key component of combination directantiviral therapy; the Company's belief that INX-189 has thepotential to play a pivotal role in future HCV combination therapy;the Company's belief that the Phase 1b data, taken together withthe successful completion of its 13-week GLP toxicology studies,support advancing INX-189 into Phase 2 clinical trials later thisyear; and the potential of INX-189 as a potent, once-daily low doseoral therapy amenable to combination with other antivirals for thetreatment of patients with all known genotypes of HCV, are forwardlooking statements. These intentions, expectations, or results maynot be achieved in the future and various important factors couldcause actual results or events to differ materially from theforward-looking statements that the Company makes, including therisk of ongoing or future clinical studies of other nucleotidepolymerase inhibitors

in development not supporting their futuredevelopment; the risk of future preclinical or clinical studies ofINX-189 not supporting its further development for lack of safety,tolerability, antiviral activity, or any other reason; INX-189 notdemonstrating sufficient anti-viral activity against HCV in futureclinical trials with a once-daily dose in combination with otherantiviral drugs; either the Company, the FDA, a safety review boardor an investigational review board suspending or terminating theclinical development of INX-189 at any time for lack of safety,tolerability, anti-viral activity, or any other reason; obtaining,maintaining and protecting the intellectual property incorporatedinto and supporting the commercial viability of the Company'sproduct candidates; and other cautionary statements containedelsewhere herein and in its Annual Report on Form 10-K for the yearended December 31, 2010, as

filed with the Securities and ExchangeCommission, or SEC, on March 16, 2011. Given these uncertainties,you should not place undue reliance on these forward-lookingstatements, which apply only as of the date of this pressrelease.There may be events in the future that the Company is unable topredict accurately, or over which it has no control. The Company'sbusiness, financial condition, results of operations and prospectsmay change. The Company may not update these forward-lookingstatements, even though its situation may change in the future,unless it has obligations under the Federal securities laws toupdate and disclose material developments related to previouslydisclosed information. The Company qualifies all of the informationcontained in this press release, and particularly itsforward-looking statements, by these cautionary statements.Inhibitex® and MSCRAMM®

areregistered trademarks of Inhibitex, Inc.Contact: Inhibitex, Inc. H. Plumb, 678-746-1136Chief Executive Officerrplumb@...orThe Trout Group

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