Skip to main content
Press Releases

FDA Grants QIDP and Fast Track Designation to CD101 Topical, Cidara Therapeutics’ Novel Antifungal Product Candidate

By May 31, 2016No Comments

-CD101 Topical designated for treatment of VVC and for prevention
of recurrent VVC-

Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives and immunotherapies to treat fungal and
other infections, today announced that the U.S. Food and Drug
Administration (FDA) has designated the company’s novel antifungal
product candidate, CD101 topical, as a Qualified Infectious Disease
Product (QIDP), with Fast Track status for its development program. The
designation is for the development of CD101 for the treatment of
vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC

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.
According to the Centers for Disease Control and Prevention (CDC),
certain species of Candida are becoming increasingly resistant to
existing antifungal medications. This emerging resistance intensifies
the need for new antifungal agents.

The QIDP designation, provided under the Generating Antibiotic
Incentives Now Act (GAIN Act), offers certain incentives for the
development of new antifungal and antibacterial drugs, including Fast
Track, priority review and, if CD101 topical is ultimately approved by
the FDA, eligibility for an additional five years of marketing

“The QIDP and Fast Track designations for CD101 topical will enable
Cidara to speed the development of this compound, which is the first
echinocandin antifungal to be developed as a topical treatment. Coupled
with the earlier QIDP and Fast Track designations for CD101 IV, we now
have the opportunity to expedite the development of CD101 for both
systemic and local fungal infections,” said Jeffrey Stein, Ph.D.,
president and chief executive officer of Cidara.

CD101 topical is the first topical agent in the echinocandin class of
antifungals and exhibits a broad spectrum of activity against Candida
species. Cidara plans to commence a Phase 2 comparative clinical trial
of CD101 topical in VVC (the RADIANT study) in mid-2016.

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 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.

To achieve QIDP designation, a drug candidate must be intended to treat
serious or life-threatening infections, particularly those caused by
bacteria and fungi that are resistant to treatment, or that treat
qualifying resistant pathogens identified by the FDA. These pathogens
include Candida species, which have the potential to pose a
serious threat to public health.

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

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

Westwicke Partners, LLC
Robert H. Uhl, 858-356-5932
Brown Inc.
Mike Beyer, 312-961-2502