High efficacy ratings further validate research on molecules anti-infective and anti-inflammatory properties
Zengen Inc. announced today positive phase I/II results for its proprietary molecule CZEN-002 for the treatment of vulvovaginal candidiasis (VVC), commonly known as vaginal yeast infection. The open label, non-randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of CZEN-002 in patients with VVC.
The majority of subjects in the study reported evidence of efficacy as determined by potassium hydroxide (KOH) tests and mycological cultures - 88.2 percent and 87.5 percent, respectively. A total of 20 female patients with VVC were enrolled and treated in the trial, and 17 completed the study. KOH testing and mycological cultures indicated that CZEN-002 is active and that five days of treatment provided positive evidence of anti-infective efficacy. CZEN-002 appeared safe and well-tolerated with no severe adverse reactions. In 100 percent of the plasma samples evaluated, concentrations of CZEN 002 were either not detected or were below the limit of quantitation.
Kumiko Hakushi | Ruder Finn, Inc
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