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 its 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. The preliminary analysis of data revealed that 72% of the patients treated with ANA598 reported undetectable levels of virus after eight weeks of the study as against 38% of those treated with placebo plus SOC.
The preliminary analysis of results through eight weeks also revealed that the ANA598 400 mg plus SOC combination was well-tolerated. Anadys stated that conclusions regarding safety and tolerability of the candidate at 400 mg dosage level cannot be drawn until results in more patients and over longer duration are available.
The preliminary analysis revealed that 32% of patients in the ANA598 400 mg twice daily plus SOC arm developed rash through eight weeks, as against 21% at week four and 41% at week 12 for those who received the combination of ANA598 200 mg twice daily and the SOC.
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.
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.
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