Topline Data Expected in First Quarter 2017
SAN DIEGO –
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,” 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170104005245/en/
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