Cidara Therapeutics Announces Publication of Results from In Vivo Study Investigating Novel Antifungal CD101 in Intra-Abdomin...
August 01 2017 - 8:30AM
Business Wire
Data published in Antimicrobial Agents and
Chemotherapy demonstrate CD101 has superior tissue and
lesion penetration compared to the current standard of care
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives including anti-infective
immunotherapies, today announced publication of data from an in
vivo study investigating the deep tissue distribution of CD101,
Cidara’s next-generation echinocandin agent, compared to the
current first-line treatment, micafungin, in the setting of
intra-abdominal candidiasis (IAC), one of the most lethal forms of
invasive candidiasis. The data were published online in
Antimicrobial Agents and Chemotherapy (AAC), a journal of the
American Society of Microbiology.
While the Infectious Diseases Society of America (IDSA)
recommends currently marketed echinocandins as first-line therapy
for most types of invasive candidiasis, failure rates of
approximately 40 percent and increasing drug resistance have raised
concerns about insufficient drug penetration during therapy for
IAC. Yanan Zhao, et. al. coordinated and conducted the CD101 IAC
study with support from the National Institutes of Health (NIH) to
help address this significant clinical need.
The study is the first to use MALDI-MS imaging, a powerful tool
that enables investigators to acquire molecular information about
drug distributions in tissues, as well as drug quantification
methods, in a clinically relevant mouse intra-abdominal abscesses
model. It compared single-dose treatments of CD101 to multiple-dose
treatments of micafungin at doses that approximated human plasma
exposures for each drug at their expected or FDA-approved clinical
dose. Results show that CD101 had a dose-dependent four-to-six-fold
superior penetration into infectious lesions days after the single
CD101 dose as compared to daily micafungin. Importantly, CD101
accumulated at levels that would be expected to prevent mutations
leading to antifungal resistance.
“The results from this cutting-edge study showcase the potential
advantages of CD101 as compared to currently marketed antifungals
to effectively treat an infection for which patients and medical
professionals desperately need new treatment options,” said Jeffrey
Stein, Ph.D., president and chief executive officer of Cidara. “The
investigators at PHRI, Rutgers University and University of
Pittsburgh should be commended for advancing antifungal drug
research with a highly novel and clinically relevant approach in
this study. These findings are especially timely given the current
outbreak of drug-resistant Candida auris, which has a reported
mortality rate as high as 60 percent.”
“The approximately 40 percent failure rate experienced by
patients with invasive candidiasis may be related to findings that
current echinocandin therapies cannot deliver sufficient
concentrations to infection sites,” said David Perlin, Ph.D.,
executive director and professor, Public Health Research Institute
(PHRI), New Jersey Medical School, Rutgers Biomedical and Health
Sciences, and senior author of the AAC paper. “The in vivo data
published in AAC confirm the potential of CD101 as a future
treatment option for patients with IAC because of the extraordinary
tissue penetration at the site of infection.”
About Fungal Infections
Approximately 97,000 Americans die from hospital-related fungal
infections each year and 90 percent of these infections are caused
by two common fungi, Candida and Aspergillus. The emergence of a
new and virulent fungal infection called Candida auris (C. auris)
is also a growing public health concern due its resistance to
existing antifungal agents. As of July 2017, the Centers for
Disease Control and Prevention (CDC) reports that C. auris has been
identified in more than 200 patients in the United States. Cidara
is currently evaluating CD101 in C. auris, in addition to multiple,
other invasive fungal infections.
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 IV, through Phase 2 and developing CD201, its bispecific
antibiotic immunotherapy, for the treatment of multi-drug resistant
Gram-negative bacterial infections. CD101 IV has improved
pharmacokinetics compared to existing echinocandins and has the
potential for expanded utility across patient settings. CD101 IV is
the only once-weekly product candidate in development for the
treatment and prevention of life-threatening invasive fungal
infections. 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 recently received a grant for up
to $6.9 million from CARB-X (Combating Antibiotic Resistant
Bacteria Accelerator) to advance the development of CD201. 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, and other attributes of CD101, including
the potential for this compound to successfully treat and prevent
fungal infections compared to current antifungal agents. 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-K 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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INVESTORS:Westwicke Partners, LLCRobert H. Uhl,
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Directorrobert.uhl@westwicke.comorMEDIA:Sam Brown
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