Cidara Therapeutics Completes Enrollment in Phase 2 RADIANT Trial Evaluating Novel Antifungal CD101 Topical in Vulvovaginal C...
January 04 2017 - 7:30AM
Business Wire
Topline Data Expected in First Quarter
2017
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.
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INVESTOR CONTACT:Westwicke Partners, LLCRobert H.
UhlManaging Director858-356-5932robert.uhl@westwicke.comorMEDIA
CONTACT:Sam Brown Inc.Christy
Curran615-414-8668ChristyCurran@sambrown.com
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