US-based biotechnology company Cidara Therapeutics has started dosing in its Phase II Radiant clinical trial for its new echinocandin, CD101, to treat acute vulvovaginal candidiasis (VVC).
Cidara’s CD101 is an antifungal drug form belonging to the echinocandin class and has a range of abilities to combat the candida species of fungus.
The multicentre, randomised, open-label, active-controlled, dose-ranging Phase II trial, Radiant will include 125 patients subjected to three forms of CD101.
In the first group of the trial, 50 patients will be applied with the CD101 Ointment.
The next cohort will involve another 50 patients treated with CD101 Gel, while the third will administer 25 patients with oral fluconazole.
The trial will focus on a primary endpoint to determine the safety and tolerability of a single dose of CD101 Ointment and multiple doses of CD101 Gel in patients with acute VVC.
The secondary endpoint focuses on determining the therapeutic efficacy of CD101 when administered to patients with acute VVC.
Cidara president and CEO Jeffrey Stein said: "Because of their excellent safety record and potency against Candida, echinocandin antifungals are recommended as first line therapy to fight systemic Candida infections.
"CD101 topical will be the first echinocandin tested clinically in VVC, and we expect to demonstrate a safe and improved eradication of Candida with rapid symptom relief for women seeking a better option over the existing azole class of antifungals."
Last month, Cidara secured the qualified infectious disease product (QIDP) and fast track designation granted by the US Food and Drug Administration (FDA) for its CD101.