OPT - 80 a new weapon in the armoury to fight Clostridium difficile ?
Perhaps there is some good news for managers of filthy, badly run NHS hospitals as Optimer Pharmaceuticals experimental drug, codename OPT-80, saw a 92.1 % rate of “cure” compared with 89.8 % in patients taking Vancocin (Vancomycin) , (made by ViroPharma of Pennsylvania) in a Phase 3 trial for the treatment of Clostridium difficile.
In addition, only 13.3% of patients treated with OPT-80 experienced a recurrence vs. 24.0% for Vancocin (p = 0.004).
The study involved 629 patients in the United States and Canada and was conducted in more than 100 clinical sites throughout North America. OPT-80 is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection.
Optimer have been conducting late-stage studies of the drug under fast-track status from the FDA, which allows it expedited review because the drug addresses a serious unmet and growing medical need.
The next step is to complete the on-going second Phase 3 study at clinical sites in Europe and North America to support an NDA filing."
The news has produced a healthy response to the shares - Optimer (Nasdaq : OPTR) .
OP- 80 a new type of antibiotic
OPT-80 is the first in a new class of antibiotics called macrocyclics, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile. The narrow spectrum profile of OPT-80 may eradicate Clostridium difficile selectively with minimal disruption to the normal intestinal flora. This may facilitate the return of the normal physiological conditions in the colon and reduce the probability of CDI recurrence.
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