– New Data Support CD101’s Potential as a Potent Treatment for
Serious Fungal Infections and Highlight Progress in Company’s Robust
Antifungal Drug-Development Program –
SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives and immunotherapies to treat fungal and
other infections, today announced the presentation of preclinical data
from studies demonstrating the unique attributes of Cidara’s lead
antifungal drug candidate, CD101, supporting its potential use for
treating serious fungal infections. The results are being presented at
the Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC) and the International Congress of Chemotherapy (ICC) joint
meeting in San Diego, September 17-21, 2015.
A total of three oral presentations and 14 posters presented at
ICAAC/ICC 2015 highlight results from a broad range of preclinical
studies evaluating Cidara’s investigational programs for CD101 IV, CD101
Topical and the Cloudbreak™ targeted immunotherapy platform. The
majority of these presentations focus on CD101 IV, providing a
description of the compound’s novel design and resulting benefits that
differentiate it from first-generation echinocandins. The preclinical
studies demonstrate that CD101 is associated with high stability and
solubility, potent antifungal activity with high efficacy in animal
models, and no toxicity signals.
“Data presented at this year’s ICAAC/ICC meeting establish the breadth,
depth and promise of our antifungal drug development program,” said Jeff
Stein, Ph.D., president and CEO of Cidara. “We anticipate that the
unique attributes of CD101 will translate into a safe, effective and
long-acting echinocandin that could benefit patients in fighting both
systemic and local fungal infections. We are extremely pleased that data
presented this week support this expectation.”
There is a significant unmet need for novel drugs to treat fungal
infections associated with high mortality rates and rising drug
resistance, typically affecting patients whose immune systems have been
compromised. In the United States alone there are an estimated 97,000
deaths per year among patients with hospital-related fungal infections,
and nearly 90 percent of these infections are caused by two fungi, Candida
and Aspergillus. CD101 IV is currently in Phase 1 clinical
development and was recently designated a Qualified Infectious Disease
Product (QIDP) with Fast Track status from the U.S. Food and Drug
Administration (FDA) for the treatment of candidemia and invasive
“Current antifungal standards of care, including first-generation
echinocandins, have multiple limitations, including inconvenient daily
IV dosing and dose-limiting toxicities,” said Dirk Thye, M.D., chief
medical officer of Cidara. “We are committed to developing a compound
that allows for safe and higher dosing on a more convenient schedule to
help physicians more effectively treat their patients.”
Highlights of Key CD101 Presentations
Title: Structure-activity Relationship of a Series of Echinocandins
and the Discovery of CD101, a Highly Stable and Soluble, Once-weekly
Novel Echinocandin; K. James, C. Laudeman, N. Malkar, R. Krishnan, K.
Polowy (Abstract F-750)
This study describes the research path to discover a novel
echinocandin with unique properties that would enable alternate routes
of administration and a flexible dosing schedule.
Researchers structurally modified multiple echinocandin platforms
through design and synthesis.
Data from this study show that the most effective compounds exhibited
half-lives four-fold (12 to 53 hours) higher than other echinocandins
in animal models. Ultimately, researchers selected for nonclinical
development the compound with the most desirable combination of
efficacy and pharmacokinetic properties – this was CD101.
The study concluded that CD101 is a novel echinocandin with a unique
modification that results in high physical and chemical stability,
solubility, and potent, efficacious antifungal activity, as well as a
very long plasma half-life compared to structurally similar compounds.
CD101’s unique properties, including its long half-life, may allow for
less frequent IV administration as well as intramuscular,
subcutaneous, and topical applications.
Title: Preclinical Evaluation Shows CD101, a Novel Echinocandin, is
Highly Stable with No Hepatotoxicity in Rats; V. Ong, G. Hough, M.
Schlosser, K. Bartizal, J. Balkovec, K. James, R. Krishnan (Abstract
This study compared the toxicity of CD101 to a first-generation
echinocandin with a focus on assessing chemical-driven liver damage,
the known dose-limiting toxicity of echinocandins in animal-safety
Using an animal-safety model, CD101 was administered by IV infusion in
doses comparable to its estimated human plasma exposures. Clinical
signs, chemistries, hematology, and liver histopathology were studied.
CD101 proved to be metabolically stable and did not exhibit
chemical-driven liver damage when given at doses up to 20 mg/kg for
Researchers concluded that the stability of CD101 prevents it from
breaking down into toxic reactive metabolites, demonstrating potential
safety in this animal model. Given that CD101 demonstrated no
toxicity, high stability, and longer half-life with lower clearance
compared to other echinocandins, it may allow for higher exposures of
the drug as a potential approach to prevent and combat drug resistance.
Title: Efficacy of CD101 to Treat Echinocandin-resistant Candida
albicans in a Murine Model of Invasive Candidiasis; Y. Zhao, I.
Kolesnikova, E. Dolgov, D. Perlin (Abstract F-748)
This study evaluated the in vivo efficacy of CD101 in treating
echinocandin-resistant strains of Candida albicans in an animal
In this study, animals were administered CD101 or micafungin at doses
that are equivalent to the anticipated human drug exposures after a
single IV dose at three hours post-inoculation.
Results show that CD101 was highly effective in treating both
echinocandin-susceptible and -resistant invasive candidiasis at
equivalent micafungin human-exposure levels and CD101 anticipated
human-exposure levels in mice.
Copies of all Cidara posters will be available at http://www.cidara.com
following the ICAAC/ICC meeting.
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, for the
treatment of serious fungal infections. CD101 IV is a long-acting
therapy for the treatment and prevention of systemic fungal infections.
CD101 Topical is for the treatment of vulvovaginal candidiasis (VVC) and
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
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 its
potential to treat infections, the incidence of fungal infections, and
the effectiveness and treatment protocols for competitive therapies.
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 documents most
recently filed with the United States Securities and Exchange Commission
(SEC), including its Quarterly Report on Form 10-Q for the quarter ended
June 30, 2015, under the heading “Risk Factors.” 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.