Cidara Therapeutics Completes Enrollment in Phase 2 STRIVE Trial Evaluating Novel Antifungal Rezafungin (CD101 IV) in Invasiv...
November 28 2017 - 7:30AM
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced the completion of patient enrollment in the STRIVE trial,
a Phase 2 randomized clinical trial evaluating the safety,
tolerability and efficacy of once-weekly dosing of its lead
antifungal candidate rezafungin acetate, formerly known as CD101
IV, compared to once-daily dosing of caspofungin in patients with
candidemia and invasive candidiasis. Rezafungin is a novel
antifungal echinocandin and is the only once-weekly product
candidate in development for the treatment and prevention of
life-threatening invasive fungal infections.
“Completion of enrollment for the STRIVE trial is an important
milestone for Cidara and our many investigators around the world
who are committed to developing and evaluating rezafungin for the
treatment and prevention of serious fungal infections,” said
Jeffrey Stein, Ph.D., president and chief executive officer of
Cidara.
Cidara expects to report topline data for STRIVE in the first
quarter of 2018, and begin Phase 3 trials for the treatment and
prophylaxis of invasive fungal infections in mid-2018. More
information about the STRIVE trial is available at
www.clinicaltrials.gov, identifier NCT02734862.
About Invasive Fungal Infections
Fungal infections can carry a mortality rate of 35-50 percent,
higher than most bacterial 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. These infections represent a significant
public health issue, particularly in highly vulnerable patient
populations at risk for infection, such as the elderly,
post-surgical, critically ill and other hospitalized patients with
serious medical conditions. There is an urgent and growing need for
new therapeutic approaches to treat and prevent serious 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,
rezafungin acetate, formerly called CD101 IV, through Phase 2 and
developing CD201, its bispecific antibiotic immunotherapy, for the
treatment of multi-drug resistant Gram-negative bacterial
infections. Rezafungin has improved pharmacokinetics compared to
existing echinocandins and has the potential for expanded utility
across patient settings. Rezafungin 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 directly kill pathogens and also direct a
patient’s immune cells to attack and eliminate bacterial, fungal or
viral pathogens. Cidara has received a grant for up to $6.9 million
from CARB-X (Combating Antibiotic Resistant Bacteria Accelerator)
to advance the development of CD201 and back-up molecules. 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 anticipated timing of topline data for the STRIVE trial, the
effectiveness, safety, and other attributes of rezafungin and CD201
and other potential product candidates, including the potential for
these compounds to successfully treat or prevent infections,
including those caused by resistant pathogens, and potentially
transform the way infectious diseases are treated, the design and
timing of rezafungin Phase 3 clinical trials, and the potential for
the Cloudbreak platform to result in future drug candidates. 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.
INVESTOR CONTACT:Robert H. UhlWestwicke
Partners, LLCManaging Director(858)
356-5932robert.uhl@westwicke.com
MEDIA CONTACT:Christy Curran Sam Brown
Inc.615-414-8668ChristyCurran@sambrown.com
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