NATAP: New HCV Nucleoside Analogue Drug

[Guest guest]

Be good to yourself,LizSome day's you're the dog, and some days you're the hydrantAttitude determines altitude. - unknown

NATAP - www.natap.org

New HCV Nucleoside Analogue Drug

SAN DIEGO--(BUSINESS WIRE)--12/17/2003--Data Presented at the

5th Biennial HEP DART Meeting on Frontiers in Drug

Development for Viral Hepatitis

Anadys Pharmaceuticals, Inc. reported yesterday at the HEP DART

2003 Meeting on Frontiers in Drug Development for Viral Hepatitis

in Kauai, Hawaii interim results from an ongoing clinical trial of

isatoribine (ANA245) that demonstrated that the drug is well

tolerated and safe at all doses that were studied. Although

efficacy is not a stated objective of the Phase IB clinical trial

and the number of patients was small, results also showed that

isatoribine reduced viral load in patients with chronic hepatitis C

virus (HCV) infection. Isatoribine is believed to act by a

mechanism involving interaction with Toll-like receptor 7 (TLR7) to

stimulate the patient's own immune system, and is one of a new

class of drugs being developed by Anadys to regulate innate

immunity, combat hepatitis C virus infection and overcome

limitations of current therapies. Although the results of

preliminary clinical trials are not necessarily predictive of

results from later-stage clinical trials with larger patient

populations, Anadys is encouraged by these early results, and

believes they provide proof of concept that a compound interacting

with TLR7 can reduce viral load in HCV infected patients. The

results were presented at the meeting by Bradley M. Kerr, Ph.D.,

Anadys' Senior Director of Clinical Affairs.

In an oral presentation, Dr. Kerr presented interim data from a

cohort treated with 800mg of isatoribine once daily, the highest

dose planned in an ongoing dose escalating open-label Phase IB

clinical trial of isatoribine administered intravenously over a

period of seven days to adults with chronic hepatitis C virus

infection. The Phase IB clinical trial is being conducted at two

clinical centers in Western Europe, and to date viral load data is

available from a total of 19 HCV infected patients who have been

dosed in four cohorts at 200mg, 400mg, 600mg and 800mg doses. The

results reported by Anadys corroborate and extend previously

disclosed safety, tolerability, and pharmacokinetic data derived

both from single doses of isatoribine in healthy volunteers, and at

lower doses in the current multiple dose Phase IB trial in HCV

infected persons. Isatoribine treatment was well tolerated, with no

serious adverse events and a low frequency of mild to moderate

adverse events. Although efficacy is not a stated objective of the

Phase IB clinical trial, at the 800mg dose isatoribine showed a

statistically significant decrease in viral load in six hepatitis C

virus infected patients.

Plasma viral load declined during treatment in all patients who

received the 800mg dose of isatoribine. The viral load difference

between the beginning and the end of treatment was statistically

significant (p=0.03), with a median change in viral load from

baseline of -0.94 log10 units. The reduction in viral load

confirmed the favorable trend seen at lower doses, and was

accompanied by changes in biologic markers of antiviral immune

response, similar to results seen at lower doses.

" The viral load reduction data generated in this trial provides

strong support for the continued development of isatoribine,

particularly since it represents a new class of agents for the

treatment of infections by hepatitis C virus " said Yves Horsmans,

M.D., Professor, Cliniques Universitaires St. Luc, Belgium, and

Principal Investigator of the study.

About isatoribine (ANA245)

Isatoribine is a patented nucleoside analog Anadys is developing

for the treatment of HCV infection. Isatoribine is one of a new

class of drugs being developed by Anadys to regulate innate

immunity, combat HCV infection and overcome limitations of current

therapies. Anadys believes isatoribine interacts with a specific

receptor, Toll-like receptor 7, or TLR7, that is present on certain

immune system cells. Although results of initial clinical trials

are not necessarily predictive of future results, interim results

of this ongoing Phase IB clinical trial showed that isatoribine

reduced viral load in hepatitis C virus infected patients. Anadys

is encouraged by these early results, and believes they provide

proof of concept that a compound interacting with TLR7 can reduce

viral load in HCV infected patients. Anadys expects to initiate a

Phase I/II clinical trial of isatoribine in selected populations of

HCV patients in the beginning of 2004.

About hepatitis C

Hepatitis C virus causes inflammation of the liver and

degradation of liver function. Hepatitis C infection is currently

the most prevalent chronic blood-borne infection in the United

States. Approximately 2.7 million people in the United States are

chronically infected with the hepatitis C virus, and it causes

10,000 to 12,000 deaths a year in the United States. The Centers

for Disease Control, or CDC, studies estimate the annual mortality

rate could increase to 38,000 by the year 2010, surpassing the

number of deaths attributed annually to HIV/AIDS. The hepatitis C

virus is transmitted primarily through significant or repeated

exposures to infected blood. Approximately two thirds of new

infections progress to chronic infection. Chronic HCV infection may

also progress to more serious complications such as cirrhosis of

the liver, liver cancer and death.

Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a

biopharmaceutical company committed to advancing patient care by

discovering, developing and commercializing novel and powerful

small molecule, anti-infective medicines for the treatment of

hepatitis C virus, or HCV, and bacterial infections. We integrate

biology and chemistry into a seamless, feedback-based, iterative

process to facilitate rapid and successful drug discovery. The

approach is designed to advance a strong and continual pipeline of

drug candidates into the clinic.

For more information, please visit www.anadyspharma.com.

CONTACT:Anadys Pharmaceuticals, Inc., San Diego Kamdar,

cc@... or Atkins + Associates Carin

Canale, ccanale@...

SOURCE: Anadys Pharmaceuticals, Inc

to get off this Email list reply with your Email address and unsubscribe in

the Subject.

[Guest guest]

NATAP: New HCV Nucleoside Analogue DrugNATAP - www.natap.orgNew HCV Nucleoside Analogue DrugSAN DIEGO--(BUSINESS WIRE)--12/17/2003--Data Presented at the5th Biennial HEP DART Meeting on Frontiers in DrugDevelopment for Viral Hepatitis Anadys Pharmaceuticals, Inc. reported yesterday at the HEP DART2003 Meeting on Frontiers in Drug Development for Viral Hepatitisin Kauai, Hawaii interim results from an ongoing clinical trial ofisatoribine (ANA245) that demonstrated that the drug is welltolerated and safe at all doses that were studied. Althoughefficacy is not a stated objective of the Phase IB clinical trialand the number of patients was small, results also showed thatisatoribine reduced viral load in patients with chronic hepatitis Cvirus (HCV) infection. Isatoribine is believed to act by amechanism involving interaction with Toll-like receptor 7 (TLR7) tostimulate the patient's own immune system, and is one of a newclass of drugs being developed by Anadys to regulate innateimmunity, combat hepatitis C virus infection and overcomelimitations of current therapies. Although the results ofpreliminary clinical trials are not necessarily predictive ofresults from later-stage clinical trials with larger patientpopulations, Anadys is encouraged by these early results, andbelieves they provide proof of concept that a compound interactingwith TLR7 can reduce viral load in HCV infected patients. Theresults were presented at the meeting by Bradley M. Kerr, Ph.D.,Anadys' Senior Director of Clinical Affairs. In an oral presentation, Dr. Kerr presented interim data from acohort treated with 800mg of isatoribine once daily, the highestdose planned in an ongoing dose escalating open-label Phase IBclinical trial of isatoribine administered intravenously over aperiod of seven days to adults with chronic hepatitis C virusinfection. The Phase IB clinical trial is being conducted at twoclinical centers in Western Europe, and to date viral load data isavailable from a total of 19 HCV infected patients who have beendosed in four cohorts at 200mg, 400mg, 600mg and 800mg doses. Theresults reported by Anadys corroborate and extend previouslydisclosed safety, tolerability, and pharmacokinetic data derivedboth from single doses of isatoribine in healthy volunteers, and atlower doses in the current multiple dose Phase IB trial in HCVinfected persons. Isatoribine treatment was well tolerated, with noserious adverse events and a low frequency of mild to moderateadverse events. Although efficacy is not a stated objective of thePhase IB clinical trial, at the 800mg dose isatoribine showed astatistically significant decrease in viral load in six hepatitis Cvirus infected patients. Plasma viral load declined during treatment in all patients whoreceived the 800mg dose of isatoribine. The viral load differencebetween the beginning and the end of treatment was statisticallysignificant (p=0.03), with a median change in viral load frombaseline of -0.94 log10 units. The reduction in viral loadconfirmed the favorable trend seen at lower doses, and wasaccompanied by changes in biologic markers of antiviral immuneresponse, similar to results seen at lower doses. "The viral load reduction data generated in this trial providesstrong support for the continued development of isatoribine,particularly since it represents a new class of agents for thetreatment of infections by hepatitis C virus" said Yves Horsmans,M.D., Professor, Cliniques Universitaires St. Luc, Belgium, andPrincipal Investigator of the study. About isatoribine (ANA245) Isatoribine is a patented nucleoside analog Anadys is developingfor the treatment of HCV infection. Isatoribine is one of a newclass of drugs being developed by Anadys to regulate innateimmunity, combat HCV infection and overcome limitations of currenttherapies. Anadys believes isatoribine interacts with a specificreceptor, Toll-like receptor 7, or TLR7, that is present on certainimmune system cells. Although results of initial clinical trialsare not necessarily predictive of future results, interim resultsof this ongoing Phase IB clinical trial showed that isatoribinereduced viral load in hepatitis C virus infected patients. Anadysis encouraged by these early results, and believes they provideproof of concept that a compound interacting with TLR7 can reduceviral load in HCV infected patients. Anadys expects to initiate aPhase I/II clinical trial of isatoribine in selected populations ofHCV patients in the beginning of 2004. About hepatitis C Hepatitis C virus causes inflammation of the liver anddegradation of liver function. Hepatitis C infection is currentlythe most prevalent chronic blood-borne infection in the UnitedStates. Approximately 2.7 million people in the United States arechronically infected with the hepatitis C virus, and it causes10,000 to 12,000 deaths a year in the United States. The Centersfor Disease Control, or CDC, studies estimate the annual mortalityrate could increase to 38,000 by the year 2010, surpassing thenumber of deaths attributed annually to HIV/AIDS. The hepatitis Cvirus is transmitted primarily through significant or repeatedexposures to infected blood. Approximately two thirds of newinfections progress to chronic infection. Chronic HCV infection mayalso progress to more serious complications such as cirrhosis ofthe liver, liver cancer and death. Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is abiopharmaceutical company committed to advancing patient care bydiscovering, developing and commercializing novel and powerfulsmall molecule, anti-infective medicines for the treatment ofhepatitis C virus, or HCV, and bacterial infections. We integratebiology and chemistry into a seamless, feedback-based, iterativeprocess to facilitate rapid and successful drug discovery. Theapproach is designed to advance a strong and continual pipeline ofdrug candidates into the clinic. For more information, please visit www.anadyspharma.com. CONTACT:Anadys Pharmaceuticals, Inc., San Diego Kamdar, cc@... or Atkins + Associates CarinCanale, ccanale@...SOURCE: Anadys Pharmaceuticals, Inc

Be good to yourself,LizSome day's you're the dog, and some days you're the hydrantAttitude determines altitude. - unknown