Cidara Therapeutics Inc. has completed patient enrollment in a phase 2 randomized trial assessing the safety, efficacy and tolerability of two topical treatment regimens of CD101, a new echinocandin antifungal, in women with acute vulvovaginal candidiasis, according to a press release.
“There have been no novel therapies approved for [vulvovaginal candidiasis (VVC)] in more than 20 years, and the azole class of therapies that are available have significant limitations,” Jeffrey Stein, PhD, president and CEO of Cidara, said in a press release. “CD101, as the first echinocandin antifungal tested in VVC, has the potential to provide women with an effective and safe topical therapy by eradicating the Candida pathogen at the site of infection.”
Researchers enrolled women with and without a history of recurrent VVC (RVVC) to evaluate the safety and tolerability of the novel topical antifungal treatment in women with moderate to severe acute episodes of VVC. They randomly assigned 125 participants into three treatment groups: 50 patients treated with CD101 gel; 50 patients received CD101 ointment and 25 patients treated with oral fluconazole.
The trial’s primary endpoint is to compare the safety and acceptability of two doses of CD101 gel with a single dose of CD101 ointment in patients with acute VVC. Researchers conducted the trial at clinical trial centers throughout the United States. Cidara plans to report topline data for the trial during the first quarter of 2017.
“Completion of enrollment for the … trial is an important milestone for Cidara as we evaluate the safety and efficacy of alternate CD101 formulations, and further assess the potential of CD101 to address the significant unmet medical need in VVC,” Stein said in the release. – by Savannah Demko
Disclosure: Stein is employed by Cidara Therapeutics.