Cidara Completes Enrollment In Phase 2 RADIANT Trial Evaluating Novel Antifungal CD101 Topical In Vulvovaginal Candidiasis

SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced the completion of patient enrollment in the RADIANT trial, a Phase 2 randomized trial evaluating the safety, tolerability and efficacy of two topical treatment regimens of the novel echinocandin antifungal, CD101, in women with moderate to severe acute vulvovaginal candidiasis (VVC). CD101 topical is the first and only agent in the echinocandin class being studied for the treatment and prevention of VVC.

“Completion of enrollment for the RADIANT 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”

“Completion of enrollment for the RADIANT 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,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “There have been no novel therapies approved for VVC in more than 20 years, and the azole class of therapies that are available have significant limitations. 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.”

RADIANT is a Phase 2, multicenter, randomized, open-label, active-controlled, dose-ranging trial designed to evaluate the safety and tolerability of CD101 topical in women with moderate to severe acute episodes of VVC. The trial includes women with and without a history of recurrent VVC (RVVC). The 125 trial participants were randomized into three treatment cohorts. The first cohort involved the treatment of 50 patients with CD101 Gel while a second cohort of 50 patients received CD101 Ointment. The third cohort comprised 25 patients who were treated with oral fluconazole.

The primary endpoint for the RADIANT trial is the safety and tolerability of two doses of CD101 Gel versus a single dose of CD101 Ointment in patients with an episode of moderate to severe acute VVC. Secondary endpoints include efficacy in women with acute VVC treated with CD101.

The trial was conducted at clinical trial centers across the United States. Cidara expects to report topline data for RADIANT in the first quarter of 2017.

More information about the trial is available at www.clinicaltrials.gov, identifier NCT02733432.

About Vulvovaginal Candidiasis

VVC is a highly prevalent mucosal fungal infection which impacts approximately 75 percent of women in America. Many have moderate to severe symptoms and four to five million are estimated to have recurrent infections. Between 30 to 40 percent of women fail acute VVC therapy and 50 percent relapse with RVVC within six months. Current therapies are fungistatic, not fungicidal (meaning they inhibit the growth of fungus but may not kill the fungus), and do not cover non-albicans Candida strains.

About CD101 Topical

CD101 topical, the first and only echinocandin antifungal being studied as a topical formulation, exhibits a broad spectrum of fungicidal activity against Candida species. In May 2016, the U.S. Food and Drug Administration (FDA) granted Qualified Infectious Disease Product (QIDP) and Fast Track Designation to CD101 topical for the treatment of VVC and the prevention of RVVC.

About Cidara Therapeutics

Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. The company is currently advancing its novel echinocandin antifungal, CD101, through Phase 2 studies in two indications and developing CD201, its bispecific antimicrobial immunotherapy, for the treatment of multi-drug resistant Gram-negative bacterial infections. CD101 IV has enhanced potency and is the only once-weekly therapy intended for the treatment and prevention of life-threatening invasive fungal infections. CD101 topical is the first and only agent of its class being studied for the treatment and prevention of vulvovaginal candidiasis (VVC), a prevalent mucosal infection. CD201 is the first drug candidate selected from Cidara’s novel Cloudbreak™ platform, the first immunotherapy discovery platform designed specifically to create compounds that direct a patient’s immune cells to attack and eliminate bacterial, fungal or viral pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effectiveness, safety, anticipated human dosing and other attributes of CD101 as a potential treatment for VVC, including the potential for CD101 to eradicate pathogens and to be superior to azoles on one or more clinical measures. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s Form 10-Q most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.