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 the first patient has been dosed
in RADIANT, a Phase 2 clinical trial comparing the safety and
tolerability of the novel echinocandin, CD101, to standard-of-care
fluconazole for the treatment of acute vulvovaginal candidiasis (VVC).
RADIANT will evaluate two topical formulations of CD101, which is
Cidara’s lead antifungal drug candidate.
“There have been no novel VVC therapies introduced for more than two
decades, so advancing CD101 topical into Phase 2 is a critical step for
women with VVC and for Cidara,” said Jeffrey Stein, Ph.D., president and
chief executive officer of Cidara. “Because of their excellent safety
record and potency against Candida, echinocandin antifungals are
recommended as first line therapy to fight systemic Candida
infections. CD101 topical will be the first echinocandin tested
clinically in VVC and we expect to demonstrate safe and improved
eradication of Candida with rapid symptom relief for women
seeking a better option over the existing azole class of antifungals.”
RADIANT is a Phase 2, multicenter, randomized, open-label,
active-controlled, dose-ranging trial designed to evaluate the safety
and tolerability of CD101 in women with moderate to severe episodes of
VVC. The study will enroll up to 125 patients who will be randomized
into three treatment cohorts. The first cohort will involve the
treatment of 50 patients with CD101 Ointment while a second cohort of 50
patients will receive CD101 Gel. The third cohort will include 25
patients who will be treated with oral fluconazole.
The primary endpoints of RADIANT will be the safety and tolerability of
a single dose of CD101 Ointment and multiple doses of CD101 Gel in
patients with acute VVC. Secondary endpoints include therapeutic
efficacy in acute VVC patients treated with CD101. Treatment evaluations
and assessments will occur on trial days 7, 14 and 28.
The RADIANT trial will be conducted at clinical trial centers across the
United States. More information about the trial is available at www.clinicaltrials.gov,
identifier NCT02733432.
About VVC and RVVC
Seventy-five percent of women worldwide suffer from VVC in their
lifetime, and four to five million women in the United States alone have
the recurrent form of the infection, which is caused by Candida.
Many women will experience recurrence after the completion of treatment
with existing therapies. Most VVC occurs in women of childbearing
potential (the infection is common in pregnant women), but it affects
women of all ages. In a recent safety communication, the U.S. Food and
Drug Administration (FDA) advised caution in the prescribing of oral
fluconazole for yeast infections during pregnancy based on a published
study concluding there is an increased risk of miscarriage. The Centers
for Disease Control and Prevention (CDC) guidelines recommend using only
topical antifungal products to treat pregnant women with vulvovaginal
yeast infections. Vaginal infections are associated with a substantial
negative impact on day-to-day functioning and adverse pregnancy outcomes
including preterm delivery, low birth weight, and increased infant
mortality in addition to predisposition to HIV/AIDS. According to the
CDC, certain species of Candida are becoming increasingly
resistant to existing antifungal medications. This emerging resistance
intensifies the need for new antifungal agents.
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.
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 of vulvovaginal candidiasis
(VVC) and the prevention of recurrent VVC (RVVC), 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.
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, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160609005334/en/
For Cidara Therapeutics:
INVESTORS:
Westwicke Partners, LLC
Robert
H. Uhl, 858-356-5932
Managing Director
robert.uhl@westwicke.com
or
MEDIA:
Sam
Brown Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com
