Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch

[Guest guest]

http://www.xconomy.com/san-diego/2009/01/08/anadys-hepatitis-c-drug-shows-quick-\

virus-killing-punch-in-small-study/

Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch

Luke Timmerman 1/8/09

An early peek at data from Anadys Pharmaceuticals (NASDAQ: ANDS) suggests the

company may have a promising new drug in the works for hepatitis C. The San

Diego-based biotech is announcing results today from the first eight patients

with the chronic liver infection, which shows its drug has more viral killing

pop in the first three days of treatment than was seen in other drugs studied in

its class, with minimal side effects.

The company found that its experimental medicine was able to wipe out 99 percent

of the virus from the blood (known as a 2.5 logarithmic reduction) within 72

hours at the lowest dose tested in a Phase I clinical trial, says CEO Steve

Worland. This finding was in the first group of patients who took a 200

milligram, twice-daily dose of ANA598. It is just the first slice of data

available, and the trial is continuing to enroll patients at two higher doses,

Worland says. The company hopes to present full data at the European Association

for the Study of the Liver meeting in Copenhagen, Denmark in April.

Today’s news will at least give Worland a fresh talking point next week when he

meets with a bunch of bummed-out investors at the JP Healthcare

Conference in San Francisco. Worland will try to cheer them up by arguing his

company’s drug is looking better at this early stage of development than others

in its class from Gilead Sciences (NASDAQ: GILD) and Pfizer (NYSE: PFE). Drugs

in this class—non-nucleoside polymerase inhibitors—aim to be fast followers in

the race to improve treatment for patients with hepatitis C, behind a group of

protease inhibitor meds.

Most researchers’ attention is now focused on a different class, protease

inhibitors like ones from Vertex Pharmaceuticals and Schering-Plough, as well as

nucleoside polymerase inhibitors like ones from Pharmasset and Roche. Since the

hepatitis C virus is a chronic infection, like HIV, many scientists believe a

cocktail of therapies with different viral killing mechanisms is the best way to

keep it in check.

“This way you can attack the virus from multiple angles,” Worland says.

Anadys (Uh-nad-iss) showed its drug appeared safe in 48 healthy volunteers, at a

variety of doses back in November. But of course, it still has a long way to go.

The company’s plan is to move later this year to a mid-stage clinical trial,

which looks at its drug in combination with pegylated interferon alpha and

ribavirin, the standard anti-viral course. It’s possible Anadys could enroll as

many as 100 patients in that trial, and design it to analyze effectiveness for

24 or 48 weeks, although the protocol hasn’t been finalized, Worland says. The

company is also doing long-term toxicity studies in animals, and working on

scaling up manufacturing, he says.

The FDA typically requires companies to first show an ability to quickly wipe

out the virus in the first three days, like the study being announced today,

before companies can move on to more rigorous long-term follow-up studies,

Worland says. Anadys plans to hold a conference call with analysts today at 8:30

am Eastern time to discuss the findings and answer questions about what comes

next.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can email

him at ltimmerman@... or call 206-624-2374.

[Guest guest]

http://www.xconomy.com/san-diego/2009/01/08/anadys-hepatitis-c-drug-shows-quick-\

virus-killing-punch-in-small-study/

Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch

Luke Timmerman 1/8/09

An early peek at data from Anadys Pharmaceuticals (NASDAQ: ANDS) suggests the

company may have a promising new drug in the works for hepatitis C. The San

Diego-based biotech is announcing results today from the first eight patients

with the chronic liver infection, which shows its drug has more viral killing

pop in the first three days of treatment than was seen in other drugs studied in

its class, with minimal side effects.

The company found that its experimental medicine was able to wipe out 99 percent

of the virus from the blood (known as a 2.5 logarithmic reduction) within 72

hours at the lowest dose tested in a Phase I clinical trial, says CEO Steve

Worland. This finding was in the first group of patients who took a 200

milligram, twice-daily dose of ANA598. It is just the first slice of data

available, and the trial is continuing to enroll patients at two higher doses,

Worland says. The company hopes to present full data at the European Association

for the Study of the Liver meeting in Copenhagen, Denmark in April.

Today’s news will at least give Worland a fresh talking point next week when he

meets with a bunch of bummed-out investors at the JP Healthcare

Conference in San Francisco. Worland will try to cheer them up by arguing his

company’s drug is looking better at this early stage of development than others

in its class from Gilead Sciences (NASDAQ: GILD) and Pfizer (NYSE: PFE). Drugs

in this class—non-nucleoside polymerase inhibitors—aim to be fast followers in

the race to improve treatment for patients with hepatitis C, behind a group of

protease inhibitor meds.

Most researchers’ attention is now focused on a different class, protease

inhibitors like ones from Vertex Pharmaceuticals and Schering-Plough, as well as

nucleoside polymerase inhibitors like ones from Pharmasset and Roche. Since the

hepatitis C virus is a chronic infection, like HIV, many scientists believe a

cocktail of therapies with different viral killing mechanisms is the best way to

keep it in check.

“This way you can attack the virus from multiple angles,” Worland says.

Anadys (Uh-nad-iss) showed its drug appeared safe in 48 healthy volunteers, at a

variety of doses back in November. But of course, it still has a long way to go.

The company’s plan is to move later this year to a mid-stage clinical trial,

which looks at its drug in combination with pegylated interferon alpha and

ribavirin, the standard anti-viral course. It’s possible Anadys could enroll as

many as 100 patients in that trial, and design it to analyze effectiveness for

24 or 48 weeks, although the protocol hasn’t been finalized, Worland says. The

company is also doing long-term toxicity studies in animals, and working on

scaling up manufacturing, he says.

The FDA typically requires companies to first show an ability to quickly wipe

out the virus in the first three days, like the study being announced today,

before companies can move on to more rigorous long-term follow-up studies,

Worland says. Anadys plans to hold a conference call with analysts today at 8:30

am Eastern time to discuss the findings and answer questions about what comes

next.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can email

him at ltimmerman@... or call 206-624-2374.

[Guest guest]

http://www.xconomy.com/san-diego/2009/01/08/anadys-hepatitis-c-drug-shows-quick-\

virus-killing-punch-in-small-study/

Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch

Luke Timmerman 1/8/09

An early peek at data from Anadys Pharmaceuticals (NASDAQ: ANDS) suggests the

company may have a promising new drug in the works for hepatitis C. The San

Diego-based biotech is announcing results today from the first eight patients

with the chronic liver infection, which shows its drug has more viral killing

pop in the first three days of treatment than was seen in other drugs studied in

its class, with minimal side effects.

The company found that its experimental medicine was able to wipe out 99 percent

of the virus from the blood (known as a 2.5 logarithmic reduction) within 72

hours at the lowest dose tested in a Phase I clinical trial, says CEO Steve

Worland. This finding was in the first group of patients who took a 200

milligram, twice-daily dose of ANA598. It is just the first slice of data

available, and the trial is continuing to enroll patients at two higher doses,

Worland says. The company hopes to present full data at the European Association

for the Study of the Liver meeting in Copenhagen, Denmark in April.

Today’s news will at least give Worland a fresh talking point next week when he

meets with a bunch of bummed-out investors at the JP Healthcare

Conference in San Francisco. Worland will try to cheer them up by arguing his

company’s drug is looking better at this early stage of development than others

in its class from Gilead Sciences (NASDAQ: GILD) and Pfizer (NYSE: PFE). Drugs

in this class—non-nucleoside polymerase inhibitors—aim to be fast followers in

the race to improve treatment for patients with hepatitis C, behind a group of

protease inhibitor meds.

Most researchers’ attention is now focused on a different class, protease

inhibitors like ones from Vertex Pharmaceuticals and Schering-Plough, as well as

nucleoside polymerase inhibitors like ones from Pharmasset and Roche. Since the

hepatitis C virus is a chronic infection, like HIV, many scientists believe a

cocktail of therapies with different viral killing mechanisms is the best way to

keep it in check.

“This way you can attack the virus from multiple angles,” Worland says.

Anadys (Uh-nad-iss) showed its drug appeared safe in 48 healthy volunteers, at a

variety of doses back in November. But of course, it still has a long way to go.

The company’s plan is to move later this year to a mid-stage clinical trial,

which looks at its drug in combination with pegylated interferon alpha and

ribavirin, the standard anti-viral course. It’s possible Anadys could enroll as

many as 100 patients in that trial, and design it to analyze effectiveness for

24 or 48 weeks, although the protocol hasn’t been finalized, Worland says. The

company is also doing long-term toxicity studies in animals, and working on

scaling up manufacturing, he says.

The FDA typically requires companies to first show an ability to quickly wipe

out the virus in the first three days, like the study being announced today,

before companies can move on to more rigorous long-term follow-up studies,

Worland says. Anadys plans to hold a conference call with analysts today at 8:30

am Eastern time to discuss the findings and answer questions about what comes

next.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can email

him at ltimmerman@... or call 206-624-2374.

[Guest guest]

http://www.xconomy.com/san-diego/2009/01/08/anadys-hepatitis-c-drug-shows-quick-\

virus-killing-punch-in-small-study/

Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch

Luke Timmerman 1/8/09

An early peek at data from Anadys Pharmaceuticals (NASDAQ: ANDS) suggests the

company may have a promising new drug in the works for hepatitis C. The San

Diego-based biotech is announcing results today from the first eight patients

with the chronic liver infection, which shows its drug has more viral killing

pop in the first three days of treatment than was seen in other drugs studied in

its class, with minimal side effects.

The company found that its experimental medicine was able to wipe out 99 percent

of the virus from the blood (known as a 2.5 logarithmic reduction) within 72

hours at the lowest dose tested in a Phase I clinical trial, says CEO Steve

Worland. This finding was in the first group of patients who took a 200

milligram, twice-daily dose of ANA598. It is just the first slice of data

available, and the trial is continuing to enroll patients at two higher doses,

Worland says. The company hopes to present full data at the European Association

for the Study of the Liver meeting in Copenhagen, Denmark in April.

Today’s news will at least give Worland a fresh talking point next week when he

meets with a bunch of bummed-out investors at the JP Healthcare

Conference in San Francisco. Worland will try to cheer them up by arguing his

company’s drug is looking better at this early stage of development than others

in its class from Gilead Sciences (NASDAQ: GILD) and Pfizer (NYSE: PFE). Drugs

in this class—non-nucleoside polymerase inhibitors—aim to be fast followers in

the race to improve treatment for patients with hepatitis C, behind a group of

protease inhibitor meds.

Most researchers’ attention is now focused on a different class, protease

inhibitors like ones from Vertex Pharmaceuticals and Schering-Plough, as well as

nucleoside polymerase inhibitors like ones from Pharmasset and Roche. Since the

hepatitis C virus is a chronic infection, like HIV, many scientists believe a

cocktail of therapies with different viral killing mechanisms is the best way to

keep it in check.

“This way you can attack the virus from multiple angles,” Worland says.

Anadys (Uh-nad-iss) showed its drug appeared safe in 48 healthy volunteers, at a

variety of doses back in November. But of course, it still has a long way to go.

The company’s plan is to move later this year to a mid-stage clinical trial,

which looks at its drug in combination with pegylated interferon alpha and

ribavirin, the standard anti-viral course. It’s possible Anadys could enroll as

many as 100 patients in that trial, and design it to analyze effectiveness for

24 or 48 weeks, although the protocol hasn’t been finalized, Worland says. The

company is also doing long-term toxicity studies in animals, and working on

scaling up manufacturing, he says.

The FDA typically requires companies to first show an ability to quickly wipe

out the virus in the first three days, like the study being announced today,

before companies can move on to more rigorous long-term follow-up studies,

Worland says. Anadys plans to hold a conference call with analysts today at 8:30

am Eastern time to discuss the findings and answer questions about what comes

next.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can email

him at ltimmerman@... or call 206-624-2374.