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ROSEVILLE, Minn.--(BUSINESS WIRE)--Rebiotix Inc. announced today that the U.S. Food and Drug Administration has approved the company’s Investigational New Drug (IND) application to begin the Phase 2 clinical study of RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). If successful, RBX2660, a preparation containing live microbes designed to rebuild a healthy intestinal microbiome, has the potential to become the first FDA-approved drug based on the human microbiome. CDI has become one of the most common health-care associated infections in the U.S., affecting more than 500,000 patients annually. The infection is characterized by profuse watery diarrhea and abdominal pain. Approximately 20 to 30 percent of patients with CDI who are treated with commonly used first-line antibiotics experience a recurrence. The risk of recurrence increases with each relapse or reinfection.
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