OPT-80, also known as PAR-101, is said to be a first in-class narrow spectrum antimicrobial agent with excellent activity against many clostridia, including Clostridium difficile, and moderate activity against certain gram-positive bacteria.
In the OPT-80 multi-center, randomized, double-blind clinical trial, the safety and efficacy of oral OPT-80 (200mg q12h) is being compared to that of oral vancomycin (125mg q6h) in subjects suffering from Clostridium difficile infection (CDI).
The study was designed to evaluate safety and compare the response to treatment by subjects during and after a 10-day course of therapy for cure, which is the primary endpoint. If cured, subjects are followed for a subsequent four-week period to evaluate recurrence, which is the secondary endpoint.
Michael Chang, CEO and president of Optimer, said: “Completing enrollment in our first OPT-80 trial is a significant step in the development of OPT-80 as an innovative therapy which may help address the global CDI health crisis. We look forward to analyzing and disclosing the data from this trial in the coming months.”