Good News for Anadys - Analyst Blog

Anadys Pharmaceuticals Inc. (ANDS) announced that its lead candidate, ANA598, which is being developed for treating patients with hepatitis C virus (HCV) infections, has met key goals in a mid-stage study.

 

The study saw HCV patients being treated with ANA598 in combination with pegylated interferon and ribavirin − the current standard of care (SOC) − at a 400 mg (twice daily) dosage level and analyzed at 12 weeks.

 

The interim data from the 12-week analysis revealed that 75% patients who received the HCV drug in combination with the SOC showed undetectable traces of the virus as against 63% of those treated with placebo plus SOC. Furthermore, 73% patients treated with the 200 mg dose of ANA598 showed undetectable levels of the virus after 12 weeks.

 

The mid-stage study is designed to evaluate the Anadys HCV candidate in combination with pegylated interferon and ribavirin at 200 mg and 400 mg dosage levels. Earlier, Anadys had reported positive results for the 200 mg dosage level.

 

The results from the 400 mg twice daily dosage level confirm positive safety results from earlier studies. Both doses of Anadys’ HCV candidate displayed demonstrated a favorable safety and tolerability profile through 12 weeks. Anadys, however, stated that conclusions regarding safety and tolerability of the candidate cannot be drawn until results in more patients and over longer duration are available.

 

Even if the Anadys candidate navigates through the clinical and regulatory hurdles smoothly, it will face tough competition in the HCV market. This market is dominated by Roche (RHHBY), which commands a majority of the US and global pegylated interferon market through the sale of Pegasys/Copegus and Merck (MRK) which sells Peg-Intron/Rebetrol.