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 Morgan 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.
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