SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that the company will present new data highlighting the
potential of rezafungin to prevent invasive fungal infections in bone
marrow transplantation (BMT) patients at the 60th American Society of
Hematology (ASH) Annual Meeting. The 2018 ASH Meeting will be held
December 1-4 in San Diego.
The rezafungin ASH abstract (2071),
titled “Pharmacokinetic-Pharmacodynamic Analyses to Provide Rezafungin
Prophylaxis Dose Selection for Prevention of Invasive Fungal Infections
for Bone Marrow Transplant Patients,” will be presented in a poster
session on Saturday, December 1. Fungal infections are a leading cause
of morbidity and mortality among immunocompromised patients,
particularly those undergoing bone marrow transplantation.
“The data we will present at ASH are important because they provide
further support that a once-weekly dosing regimen of rezafungin can help
to prevent life-threatening fungal infections in high-risk patients,”
said Jeffrey Stein, Ph.D., president and chief executive officer of
Cidara. “We believe rezafungin can address this serious unmet medical
need in immunocompromised patients and has the potential to be the only
single agent approved to prevent infections caused by common fungal
pathogens in bone marrow transplant patients.”
Rezafungin is a novel antifungal echinocandin being developed as a
once-weekly therapy for the treatment and prevention of serious invasive
fungal infections. Rezafungin is being developed to address unmet needs
in the treatment of candidemia and invasive candidiasis as well as for
prophylaxis of invasive fungal infections due to the common fungal
pathogens Candida, Aspergillus and Pneumocystis.
Cidara plans to start the Phase 3 ReSPECT prophylaxis clinical trial of
rezafungin in patients undergoing allogeneic bone marrow transplantation
in the first quarter of 2019.
About Invasive Fungal Infections
Approximately 97,000 Americans die from hospital-related invasive fungal
infections each year and 90 percent of these infections are caused by
two common fungi, Candida and Aspergillus. Pneumocystis
Pneumonia (PCP) is another serious fungal infection that commonly
afflicts people with weakened immune systems. Systemic fungal infections
typically affect patients whose immune systems have been compromised,
such as patients undergoing organ or bone marrow transplantation or
chemotherapy, including patients with hematologic malignancies, or
patients in intensive care units and those with prolonged hospital stays.
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 potential for rezafungin to be a novel
treatment and prophylactic agent against deadly invasive fungal
infections, statements regarding the potential for expanded utility
across patient settings, such as immunocompromised patients, as well as
statements regarding rezafungin’s ability to mitigate the challenges
typically associated with prophylaxis of invasive fungal infections in
immunocompromised and bone marrow transplant patients, and statements
regarding the time of initiation of rezafungin Phase 3 pivotal trials.
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/20181127005460/en/
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing
Director
(858) 356-5932
robert.uhl@westwicke.com
MEDIA CONTACT:
Christy Curran
Sam Brown Inc.
615-414-8668
ChristyCurran@sambrown.com
