Cidara Therapeutics Presents Results from Successful Phase 2 STRIVE Trial Evaluating Rezafungin at IDWeek 2018
October 04 2018 - 8:00AM
Business Wire
- 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
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.
- 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.
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Cidara Therapeutics, Inc.INVESTOR CONTACT:Westwicke
Partners, LLCRobert H. UhlManaging
Director858-356-5932robert.uhl@westwicke.comorMEDIA
CONTACT:Sam Brown Inc.Christy
Curran615-414-8668ChristyCurran@sambrown.com
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