Santarus, a specialty biopharmaceutical company, has reported positive results from a Phase III study of rifamycin SV MMX in patients with travelers’ diarrhoea.
The study, which is designed to evaluate the safety and efficacy of rifamycin SV MMX, has met the primary endpoint of reducing time to last unformed stool (TLUS) in patients with travelers’ diarrhoea.
Santarus research and development executive vice president Dr Wendell Wierenga said the results are a key milestone in developing the drug for the US market.
"Rifamycin SV is an investigational broad spectrum, non-systemic antibiotic that has been used for more than 20 years in Europe in both intravenous and intramuscular forms, but is considered a new chemical entity in the US," Wierenga said.
According to the study data, in the intent-to-treat population, the median TLUS was 46.0 hours for rifamycin SV, compared to 68.0 hours for placebo, with similar results in the per protocol population.
Rifamycin SV was generally well tolerated in the study and the frequency of treatment emergent adverse events was similar to placebo.
Santarus previously signed a licensing deal with Cosmo Technologies to develop and commercialise rifamycin SV MMX in the US.
Cosmo’s European development partner, Dr. Falk Pharma, is conducting a second Phase III study to evaluate the efficacy of rifamycin SV versus ciprofloxacin with the primary endpoint of TLUS in patients with travelers’ diarrhoea.
Anticipating positive second Phase III study results, Santarus and Dr. Falk plan to share the clinical data from their respective studies to include in both company’s regulatory submissions.