SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that data from preclinical studies evaluating its novel Phase 2 echinocandin CD101 as a topical treatment for vulvovaginal candidiasis (VVC) will be presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) in Annapolis, Maryland from August 11-13, 2016. Results from a national survey of 478 U.S. women with VVC will also be presented.
The IDSOG Scientific Program Committee selected Cidara’s abstracts for one oral and two poster presentations at the meeting. The presentations will highlight attributes of the company’s lead antifungal drug candidate CD101 topical as a potential treatment for VVC, and report on new research investigating the unmet needs in VVC treatment based on patient-reported measures.
“Our presence at this year’s IDSOG meeting underscores the importance that we and the broader scientific community place on advancing CD101 topical as the first echinocandin antifungal being studied in VVC,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “There have been no novel therapies approved for VVC in over 20 years, and CD101 has the potential to provide a safe and effective new option for the millions of women who suffer from acute and recurrent infections.”
Details for the Cidara IDSOG 2016 presentations are as follows:
Saturday, August 13 (9:25 a.m. - 9:40 a.m. ET, The Westin Annapolis, Capitol D)
Time-Kill Kinetics of the Novel Echinocandin CD101 for
Azole-Susceptible and -Resistant Candida spp. at pH 4 in
Vagina-Simulative Medium; J. Locke, et. al.
- This study investigated the killing kinetics of CD101 against Candida spp., including azole-S and -R strains, in conditions and at concentrations relevant to topical treatment of VVC.
Thursday, August 11 (2:30 p.m. – 4:00 p.m. ET, The Westin Annapolis, Capitol ABC)
CD101 Gel Formulation is Highly Efficacious Against Azole-Resistant C.
albicans in a Rat Model of VVC; V. Ong, et. al.
- This study evaluated the efficacy of the gel formulation of CD101 compared to marketed miconazole and nystatin creams and oral fluconazole in an immunosuppressed rat model of VVC.
Characterizing Women in the U.S. with Acute and Recurrent Vulvovaginal
Candidiasis and their Unmet Needs; P. Daruwala, et. al.
- This poster will summarize results from an online survey of 478 women in the U.S. with either recurrent VVC, mild acute VVC or moderate to severe acute VVC. The survey was designed to identify differences in characteristics and attitudes related to VVC treatment and unmet needs in the current treatment paradigm.
Copies of these presentations and posters will be available on the Cidara website following the IDSOG 2016 meeting: http://www.Cidara.com/
About CD101 Topical
CD101 topical is the first topical agent in the echinocandin class of antifungals and exhibits a broad spectrum of fungicidal activity against Candida species. In May 2016, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track Designation to CD101 topical for the treatment of VVC and the prevention of RVVC. A Phase 2 clinical trial, called RADIANT, is currently underway comparing the safety and tolerability of CD101 to fluconazole for the treatment of acute VVC.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard-of-care therapies. Cidara's initial product portfolio comprises two formulations of the company's novel echinocandin, CD101. CD101 IV is being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious, invasive fungal infections. CD101 topical is being developed for the treatment and prevention of vulvovaginal candidiasis (VVC), a prevalent mucosal infection. In addition, Cidara has developed a proprietary immunotherapy platform, Cloudbreak™, designed to create compounds that direct a patient's immune cells to attack and eliminate pathogens that cause infectious disease. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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, long-acting nature, anticipated human dosing and other attributes of CD101 IV and CD101 topical, and their potential to treat infections, as well as the intended design of current and future Cloudbreak compounds. 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.