Cidara fails phase 2 study, drops med in vulvovaginal candidiasis

The small cap was down 40% premarket on the news this morning

Cidara Therapeutics will stop work on its antifungal CD101 in women with moderate-to-severe acute vulvovaginal candidiasis (VVC), after the topical candidate failed a mid-stage trial.

The so-called ‘Radiant’ phase 2 tested gel and ointment forms of echinocandin antifungal CD101 in VVC patients against the marketed antifungal fluconazole in an oral form—but failed to show sufficient efficacy. Topical forms of CD101 will not be discontinued, the biotech said in a statement.

“The study found that the gel and ointment topical formulations of CD101 evaluated in Radiant were similar in efficacy to each other but lower in clinical and mycological cure rates compared to oral fluconazole,” the biotech added.

It will now focus on an IV version of the drug—currently being studied in phase 2 for candidemia—and the expansion and acceleration of the Cloudbreak immunotherapy platform, which includes CD201 for the treatment of infections caused by multi-drug resistant Gram-negative bacteria.

The IV test, known as the Strive trial, “remains on track,” and is looking at the safety and efficacy of once-weekly CD101 IV to caspofungin, with an optional step-down to oral fluconazole. Results from the test are slated for the fourth quarter of this year.

The small-cap company was pummelled premarket, down 40% to around $7 a share on the news.