Presentations Will Highlight Data from Studies of Novel
Echinocandin CD101 and Reinforce the Unmet Need for Effective New VVC
SAN DIEGO –
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
“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
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,
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.
- This study investigated the killing kinetics of CD101 against Candida
Thursday, August 11 (2:30 p.m. – 4:00 p.m. ET, The Westin Annapolis,
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.
- This study evaluated the efficacy of the gel formulation of CD101
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.
- This poster will summarize results from an online survey of 478
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