Four accepted presentations include a late-breaker featuring Phase
2 STRIVE trial data and three posters describing the activity of
rezafungin against fungal pathogens
SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that it will present four posters highlighting data from
preclinical studies and a clinical trial of rezafungin, its lead
antifungal product candidate, at the American Society for Microbiology
(ASM) Microbe 2018, being held June 7-11 in Atlanta. Cidara’s
presentations will include a late-breaker poster detailing results from
the Phase 2 STRIVE clinical trial, which evaluated rezafungin as a
once-weekly, high-exposure intravenous therapy for the treatment of
serious invasive fungal infections. Preclinical data to be presented
include evaluation of the mutant prevention concentration of rezafungin,
which may indicate a potential to suppress antifungal resistance.
“At ASM Microbe 2018, we will present topline results from Part A of our
multinational STRIVE trial that demonstrated the efficacy and safety of
rezafungin and its potential as a once-weekly treatment option for
patients with difficult-to-treat and often deadly invasive Candida
infections. These data provide support for the advancement of rezafungin
into Phase 3 pivotal trials in both treatment and prophylaxis,” said
Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
“In the face of significant unmet needs in the prevention and treatment
of invasive fungal infections and the challenges of antifungal
resistance, we are pleased to share our latest findings and add to the
growing body of data demonstrating the expanded clinical utility of
rezafungin.”
ASM Microbe 2018 is the main forum for microbial sciences and considers
and debates scientific issues, connects scientists and explores the
complete spectrum of microbiology from basic science to translation and
application. Details of Cidara’s poster presentations at the forum are
as follows:
Title: Clinical Efficacy and Safety of Rezafungin (CD101):
Results from STRIVE, a Randomized, Double-blind, Multicenter, Phase 2
Study in the Treatment of Candidemia and/or Invasive Candidiasis
Presenter:
T. Sandison
Date and time: Friday, June 8, 11:00 a.m. – 1:00
p.m. Eastern Time
Location: Exhibit and Poster Hall,
Building B, Halls B2-B5
Session 048: FRIDAY – AAR
Late-breakers
Poster number: FRIDAY-AAR LB21
Title: Activity of a Long-Acting Echinocandin Rezafungin (CD101)
and Comparator Antifungal Agents Tested against Contemporary Invasive
Fungal Isolates: SENTRY 2016
Presenter: M. Castanheira
Date
and time: Friday, June 8, 11:00 a.m. – 1:00 p.m. Eastern Time
Location:
Exhibit and Poster Hall, Building B, Halls B2-B5
Session 054:
AAR03 – Antifungal Agents and Resistance: Agents to Treat Fungal
Infections
Poster number: FRIDAY-485
Title: CD101 Exhibits Low Minimum Inhibitory and Mutant
Prevention Concentrations against Candida glabrata Clinical
Isolates
Presenter: K. Squires
Date and time: Friday,
June 8, 11:00 a.m. – 1:00 p.m. Eastern Time
Location: Exhibit
and Poster Hall, Building B, Halls B2-B5
Session 054: AAR03
– Antifungal Agents and Resistance: Agents to Treat Fungal Infections
Poster
number: FRIDAY-496
Title: Establishment of Quality Control Ranges for the Broth
Microdilution Susceptibility Testing of Rezafungin against Yeast
Presenter:
C. Pillar
Date and time: Friday, June 8, 11:00 a.m. – 1:00
p.m. Eastern Time
Location: Exhibit and Poster Hall,
Building B, Halls B2-B5
Session 054: AAR03 – Antifungal
Agents and Resistance: Agents to Treat Fungal Infections
Poster
number: FRIDAY-507
Copies of these presentations will be available on the Cidara website
following the meeting: www.cidara.com
About STRIVE
STRIVE is an international, multicenter, double-blind, Phase 2 trial
evaluating the safety, tolerability and efficacy of once-weekly dosing
of rezafungin acetate compared to once-daily dosing of caspofungin in
patients with candidemia and/or invasive candidiasis. The STRIVE trial
results (Part A) include efficacy data from 92 treated patients (mITT
population), and safety and tolerability results in 104 patients from 31
trial sites in North America and Europe. The trial was not statistically
powered to demonstrate superiority or non-inferiority and, therefore,
comparisons of efficacy are directional.
STRIVE Part A met all of its primary objectives, as once-weekly
intravenous dosing of rezafungin was observed to be generally well
tolerated and safe in patients with candidemia and/or invasive
candidiasis. The results also provide evidence of rezafungin efficacy,
which was defined in the trial by clearance of Candida from the
blood or other normally sterile sites, resolution of signs related to
the infection, investigator assessment of clinical response, and overall
survival.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) represent a serious threat to millions
of patients worldwide, resulting in more than 1.5 million deaths
annually and mortality rates ranging from 15 to 65 percent. These
infections continue to be a global health issue, especially for
critically ill patients in hospitals and patients with compromised
immune systems, including cancer and transplant patients. Approximately
90 percent of IFI-related deaths are associated with Candida, Aspergillus,
and Pneumocystis.
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, rezafungin acetate,
formerly known as CD101 IV, through clinical trials. Rezafungin has
improved pharmacokinetics compared to existing echinocandins and the
potential for expanded utility across patient settings. It is the only
once-weekly product candidate in development for the treatment and
prevention of life-threatening invasive fungal infections. The company’s
Phase 2 STRIVE clinical trial of rezafungin met its primary safety and
efficacy objectives, and provide support for Cidara to initiate Phase 3
pivotal trials in the treatment of candidemia and invasive candidiasis
and the prophylaxis of invasive fungal infections. Cidara also is
leveraging its novel Cloudbreak™ platform to develop antibody-drug
conjugates for the treatment of multi-drug resistant Gram-negative
bacterial infections. Cloudbreak is the first immunotherapy discovery
platform designed specifically to create compounds that directly kill
pathogens and also 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, the potential for rezafungin to successfully treat or prevent
invasive fungal infections and represent an improvement over current
approaches, and Cidara’s ability to successfully develop rezafungin.
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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or
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