Nitazoxanide plus SOC achieves SVR24 of 79%

Privately-held US drug developer Romark Laboratories says that data on its drug candidate nitazoxanide, presented at the 43rd annual meeting of the European Association for the Study of the Liver, in Milan, Italy, confirm earlier research suggesting synergistic activity between nitazoxanide and peginterferon in genotype 4 patients. These also provide a first look at sustained virologic response in a limited number of genotype 1 patients. Jean-Francois Rossignol, director of the Romark Institute for Medical Research, said these data also provide insights into the mechanism of action of nitazoxanide and confirm previous findings related to its safety.

In the STEALTH C-1 trial, treatment-naive patients on combination therapy with nitazoxanide plus standard-of-care saw a SVR24 rate of 79%, compared with 50% for those treated with SOC without nitazoxanide (p=0.023). When nitazoxanide was combined with peginterferon alone, the observed SVR24 rate in this group was 61%. In 24 treatment-experienced patients, the addition of nitazoxanide to SOC for 36 weeks resulted in a 25% rate of SVR, compared with 8% when nitazoxanide was combined with peginterferon alone. The people treated with nitazoxanide experienced no more side effects than those who received the SOC, Romark noted. The firm is currently enrolling patients for two US clinical trials studying nitazoxanide for hepatitis C genotype 1.