Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that is has begun to enroll patients in the first study in its Phase III clinical program to evaluate the efficacy and safety of rifamycin SV MMX® for the treatment of patients with travelers’ diarrhea.
“The Ministries of Health in Mexico and Guatemala have approved our clinical trial applications for the Phase III study with rifamycin SV MMX, and we are beginning to enroll patients at clinical sites in these countries,” said E. David Ballard, M.D., senior vice president, clinical research and medical affairs of Santarus. “Our plan for patient enrollment is to coincide with the peak summer travel season.”
He added, “Rifamycin SV has been used for more than 20 years in Europe in both intravenous and intramuscular dosage forms and has had a good safety profile. Rifamycin SV has also demonstrated a broad spectrum of in vitro activity targeted to the main enteropathogens that cause travelers’ diarrhea.”
The principal investigator for the Phase III clinical study is Herbert L. DuPont, M.D., Director of the Center for Infectious Diseases and Professor of Epidemiology at the University of Texas – Houston School of Public Health, Chief of Internal Medicine at St. Luke’s Hospital and Vice Chairman, Department of Medicine and Clinical Professor at the Baylor College of Medicine. Dr. DuPont is a recognized expert in public health and infectious diseases with an emphasis on travelers’ diarrhea.
In the Phase III clinical program, Santarus plans to undertake two international multicenter, randomized, double-blind studies, each with up to approximately 300 patients, to assess the efficacy and safety of rifamycin SV MMX 400 mg (2 times 200 mg) oral tablets taken twice daily (800 mg total daily dose) for three days versus placebo in the treatment of patients with travelers’ diarrhea. The primary endpoint of the Phase III clinical studies will be the time to last unformed stool (TLUS) and the studies will seek to demonstrate the superiority of rifamycin SV MMX to placebo.
Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic with negligible systemic absorption, which is being developed for the treatment of patients with travelers’ diarrhea and potentially for other diseases that have an infectious component in the colon. Due to the negligible systemic absorption of rifamycin SV, the company believes that rifamycin SV MMX will offer an opportunity for limited side effects and will be less prone to the development of antibiotic-resistant strains of bacteria, a major concern with systemically delivered antibiotics.
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