Cidara Touts Positive Phase II Antifungal Data

Shares of Cidara Therapeutics have fallen more than 22 percent this morning despite the company reporting its mid-stage antifungal candidate hit its primary endpoints and is on track to begin Phase III testing later this year.

Initially, company stock jumped about 14 percent in premarket trading but began to fall when the markets opened this morning. Although the company touted good news, investors apparently seem unsure of what to make of it.

San Diego-based Cidara said is Phase II STRIVE trial, which was testing its lead antifungal candidate rezafungin acetate (formerly called CD101), met all of its primary objectives. The trial was testing the medication as a treatment for patients with candidemia and/or invasive candidiasis. Additionally, the company said the once-per-week intravenous treatment was well-tolerated in patients. Cidara’s rezafungin is a novel antifungal echinocandin being developed as a "once-weekly, high-exposure therapy" for the treatment and prevention of serious invasive fungal infections. Data showed the group dosed with 400mg/200mg had the highest efficacy rate of all three groups dosed during the trial, the company said.

That was good news for the company, which saw a dramatic failure from a mid-stage treatment a little more than a year ago. That failure forced the company to discontinue development of the VVC treatment program. In February 2017 the company said its topical version of rezafungin (CD101) for the treatment of acute vulvovaginal candidiasis failed to show any kind of treatment advantage that would warrant continued development. After that failure, the company dumped the topical version for a focus on the intravenous formulation.

Today data from the Phase II STRIVE trial showed rezafungin was able to clear candida from the blood and resolved signs related to the infection.

"This is the first time that any antifungal has shown the potential to be a safe and effective once-weekly treatment option for patients with difficult-to-treat and deadly invasive Candida infections, which may enable patients to leave the hospital earlier, saving money and improving care," Cidara Chief Executive Officer Jeffrey Stein said in a statement. "It is especially encouraging to note the consistent trends in relative outcomes improvement among patients on the rezafungin 400/200 regimen as compared to those on the comparator caspofungin."

Pointing to the Phase II data, Stein said the company was confident in selecting dosing regimens for the upcoming Phase III treatments. When the Phase III programs are launched Cidara said it will study rezafungin across distinct and large patient populations where there is an urgent need for innovation. The treatment trial will evaluate rezafungin as a treatment for Candida infections and enable hospital discharge on an echinocandin with once-weekly dosing.

The Phase II trial reported efficacy data from 92 patients and safety and tolerability reports from 104 patients. The company noted that the trial was not designed to demonstrate if rezafungin was superior to another product.

Shares of Cidara are trading at $6.40 as of 10:45 a.m. The stock closed at $7.90 per share on March 16.

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