-
STRIVE clinical trial successfully met all primary endpoints
demonstrating the efficacy and safety of rezafungin for the treatment
of invasive fungal infections -
Rezafungin data featured in one oral and three poster
presentations showcase broad clinical utility of Cidara’s novel
once-weekly antifungal agent
SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced the presentation of data from the company’s Phase 2 STRIVE
trial of rezafungin at IDWeek
2018, taking place in San Francisco from October 3-7. The STRIVE
trial successfully achieved its primary endpoints, demonstrating the
efficacy and safety of once-weekly dosing of rezafungin compared to
once-daily dosing of caspofungin in patients with candidemia and/or
invasive candidiasis. Results from the STRIVE trial will be featured in
an oral abstract session along with three additional rezafungin poster
presentations which showcase the broad clinical utility of Cidara’s
novel once-weekly antifungal agent.
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The Impact of Invasive Fungal Infections (Graphic: Business Wire)
“The additional detail from the Phase 2 STRIVE trial bolsters our
confidence in achieving the objectives of the recently initiated Phase 3
ReSTORE trial,” said Jeffrey Stein, Ph.D., president and chief executive
officer of Cidara. “We believe that rezafungin has the potential to
provide an important new treatment option for patients with potentially
deadly invasive fungal infections.”
The STRIVE data will be presented by George R. Thompson, M.D., Principal
Investigator for the trial, during the oral abstract session, Clinical
Trials That May Change Your Practice, on Saturday, October 6, 2018 at
9:30 a.m. Pacific Time
“The data from the Phase 2 STRIVE trial provide evidence of rezafungin’s
safety and potent efficacy against Candida infections,” said Dr.
Thompson, Associate Professor of Clinical Medicine at the University of
California, Davis, School of Medicine and the Departments of Medical
Microbiology and Immunology, and Internal Medicine, Division of
Infectious Diseases. “The potential of rezafungin to achieve higher drug
exposures to treat invasive Candida disease as well as the
potential for easy once-weekly outpatient use could be practice-changing
in many clinical situations.”
STRIVE was 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 (IC). STRIVE met
all of its primary objectives: once-weekly intravenous (IV) dosing of
rezafungin at two dosing regimens was observed to be generally well
tolerated and safe in patients with candidemia and/or IC. The data also
provide evidence of rezafungin efficacy, which was defined in the trial
by clearance of Candida from the blood or other normally sterile
sites (mycological response), resolution of signs related to the
infection (investigator assessment of clinical response) and overall
survival.
Key findings from the three rezafungin IDWeek poster presentations are
summarized below.
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Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses
to Support Rezafungin (RZF) Dose Selection in Treatment of Candida;
E.A. Lakota, et. al.
Using a simulation model, this study
evaluated two IV dosing regimens of either 400 mg of rezafungin
administered once weekly or 400 mg on Week one, then 200 mg once
weekly thereafter. Researchers concluded that rezafungin achieved high
target attainment against C. albicans and C. glabrata
with both regimens, supporting Phase 3 dose selection for the
treatment of patients with candidemia or IC. -
Activity of a Long-Acting Echinocandin, Rezafungin, Tested against
Invasive Fungal Isolates Collected Worldwide; Mariana Castanheira,
PhD, et. al.
The results from this study compared the in
vitro activity of rezafungin to other antifungals (e.g., azoles
and first-generation echinocandins) against 719 clinical isolates from
invasive fungal infections collected worldwide during 2017. The study
concluded that rezafungin demonstrated potent activity against this
global panel of clinical isolates of Candida and Aspergillus species.
The authors noted the potential of rezafungin in prevention and
treatment of invasive fungal infections, including in outpatient
settings. -
Effect of Rezafungin on QT Interval in Healthy Subjects; S.
Flanagan, et. al.
This study highlights results from a Phase
1, single-center, randomized, comparative trial of single doses of IV
rezafungin, IV placebo, and oral moxifloxacin (positive control) in
healthy adult subjects. As some antifungals, such as azoles, are
associated with QT prolongation and risk of potentially fatal cardiac
irregularities (e.g., torsades de pointes – a serious heart rhythm
disturbance), the primary objective was to assess the effects of
rezafungin on QT interval. Results showed that rezafungin in single
doses up to 1400 mg IV had no significant effect on QT prolongation or
on any of the other cardiac conduction parameters tested.
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 hospital deaths in the U.S. are associated with Candida
and Aspergillus.
Copies of all IDWeek presentations will be available on the Cidara
website following the meeting: www.cidara.com.
About Rezafungin
Rezafungin is a novel antifungal echinocandin being developed as a
once-weekly, high-exposure therapy for the treatment and prevention of
serious invasive fungal infections. Rezafungin has a unique
pharmacokinetic profile with a prolonged half-life and front-loaded
plasma exposure which, in contrast to all other echinocandins, allows
for once-weekly IV therapy. Rezafungin is being studied to address unmet
needs in the treatment of candidemia and invasive candidiasis as well as
for prophylaxis (prevention) of invasive fungal infections, including Candida,
Aspergillus and Pneumocystis, in patients with hematologic
malignancies undergoing allogeneic bone marrow transplantation.
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, in a
Phase 3 clinical trial in the treatment of candidemia and invasive
candidiasis and plans to initiate a second Phase 3 trial in the
prophylaxis of invasive fungal infections. 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. Cidara also is leveraging
its novel Cloudbreak™ platform to develop antibody-drug conjugates for
the treatment of serious viral and 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, statements regarding the initiation of rezafungin Phase 3 pivotal
trials, the potential for rezafungin to be a novel treatment and
prophylactic agent against deadly invasive fungal infections, and
represent an improvement over current approaches, rezafungin’s potential
for expanded utility across patient settings; and rezafungin’s potential
to be practice-changing. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181004005151/en/
Cidara Therapeutics, Inc.
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Robert H. Uhl
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