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FDA Grants QIDP and Fast Track Designation to CD101 Topical, Cidara Therapeutics’ Novel Antifungal Product Candidate
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-CD101 Topical designated for treatment of VVC and for prevention of recurrent VVC-
Seventy-five percent of women worldwide suffer from VVC in their
lifetime, and four to five million women in
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
“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
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
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
About
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
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20160531005335/en/
Source:
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