Cidara Therapeutics Initiates Phase 3 Trial of Lead Antifungal Rezafungin for Treatment of Invasive Candida Infections
27 September 2018 - 10:00PM
Business Wire
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology
company developing novel anti-infectives including immunotherapies,
today announced that the first trial site has been activated for
ReSTORE, a Phase 3 clinical trial evaluating the efficacy and
safety of the company’s lead antifungal, rezafungin, to treat
candidemia and invasive candidiasis. Rezafungin is a novel
echinocandin antifungal being developed as a once-weekly,
high-exposure therapy for the treatment and prevention of serious
invasive fungal infections.
“Given the compelling data from our Phase 2 program, we are very
pleased to initiate our global Phase 3 program of rezafungin,” said
Jeffrey Stein, Ph.D., president and chief executive officer of
Cidara. “Difficult-to-treat, invasive Candida infections are
associated with a high mortality and affect the most vulnerable
patients. Rezafungin has the potential to be the first new
antifungal approved for this indication in over a decade and, given
how the drug works, it has the potential to improve outcomes for
patients and allow them to leave the hospital earlier, resulting in
reduced healthcare costs.”
ReSTORE is a global, randomized, double-blind, controlled Phase
3 pivotal clinical trial evaluating the efficacy and safety of
once-weekly intravenous dosing of rezafungin compared to once-daily
dosing of caspofungin in patients with candidemia and/or invasive
candidiasis. The trial design will be similar to the company’s
Phase 2 STRIVE study, which met its primary safety and efficacy
objectives. The ReSTORE trial is designed to evaluate one
rezafungin dosing regimen of 400 milligrams (mg) for the first week
followed by 200 mg of rezafungin once weekly for up to four weeks
in total. This treatment arm will be compared to caspofungin in a
1:1 randomization.
The primary efficacy endpoint of ReSTORE, which will be used for
a U.S. Food and Drug Administration (FDA) New Drug Application
submission, is all-cause mortality at day 30. The primary efficacy
endpoint for the European Medicines Agency (EMA) is expected to be
global response at day 14.
“I am very enthusiastic about the initiation of this important
trial of rezafungin as a once-weekly echinocandin which may offer a
new solution for patients and physicians to treat serious invasive
Candida infections,” said Cornelius J. Clancy, M.D., Associate
Professor of Medicine and Director of the Mycology Research Unit
and XDR Pathogen Lab at the University of Pittsburgh. “There is an
urgent and growing need for new therapeutic approaches for these
infections, which typically afflict highly vulnerable patients,
including those who are critically ill and have compromised immune
systems. Rezafungin has the potential to overcome the significant
limitations associated with current standards of care such as
sub-optimal dosing, increasing resistance, drug-drug interactions
and toxicities, all of which complicate therapy in patients who are
already ill.”
The ReSTORE trial will enroll approximately 184 modified
intent-to-treat, or mITT, patients and is expected to generate
topline data in 2020. This global trial is anticipated to be
conducted at approximately 100 clinical trial centers across the
United States, Europe, Asia and Australia.
About Candidemia/Invasive Candidiasis
Over 90 percent of invasive fungal infections begin in the
hospital setting. Invasive candidiasis and candidemia comprise the
majority of invasive fungal infections in intensive care units,
internal medicine and hematology wards within hospitals. Invasive
candida infections are considered to be serious and
life-threatening and are associated with high rates of morbidity
and mortality. According to the Centers for Disease Control and
Prevention (CDC) surveillance data, the 30-day all-cause mortality
among people with candidemia is approximately 30 percent.
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 undergoing an allogeneic bone marrow
transplant. In the recent Phase 2 STRIVE trial, data showed that
once-weekly intravenous dosing of rezafungin was generally well
tolerated and safe in patients with candidemia and/or invasive
candidiasis.
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 provides 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 is also 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, Cidara’s ability to
successfully commence and complete Phase 3 clinical trials, the
design and timing of those clinical trials, 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 complete development of
rezafungin and receive regulatory approval for any indication.
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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