SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that three rezafungin abstracts have been accepted for
presentation at the 45th Annual European Society for Blood
and Marrow Transplantation (EBMT) Meeting to be held in Frankfurt,
Germany from March 24-27, 2019. Rezafungin is a novel echinocandin
antifungal and is the only once-weekly product candidate in development
for the treatment and prevention of life-threatening invasive fungal
infections.
“Patients undergoing blood and marrow transplantation are at increased
risk of acquiring deadly invasive fungal infections and current
prevention strategies require multiple antifungals that are associated
with known drug-drug interactions as well as safety and tolerability
issues,” said Jeffrey Stein, Ph.D., president and chief executive
officer of Cidara. “We believe rezafungin has the potential to transform
the fungal prevention paradigm in vulnerable transplant patients by
providing a simple one-drug regimen with a potentially superior safety
profile.”
The EBMT annual meeting is the Society’s flagship scientific forum that
convenes scientists, healthcare professionals, and patients from Europe
and throughout the world to discuss key issues and developments relating
to stem cell transplantation and cellular therapy research.
Rezafungin data will be featured in three poster presentations during
the Infectious Complications Poster Session, taking place on Tuesday,
March 26 from 17:30-19:00 (Central European Time) in the Forum Building,
Level 0. Presentation details are as follows:
Title: Drug-Drug Interaction (DDI) Study Between Rezafungin and Nine
Probe Drugs Show No Relevant Pharmacokinetic Change
Abstract
number: B196
Presenter: V. Ong
Title: Pharmacokinetic-Pharmacodynamic Analyses of Dose Selection for
Rezafungin Prophylaxis Against Invasive Fungal Infections in Blood and
Marrow Transplantation
Abstract number: B214
Presenter: V. Ong
Title: Rezafungin Prophylactic Efficacy in a Mouse Model of Pneumocystis
Pneumonia
Abstract number: B189
Presenter: T. Sandison
Full abstracts for these studies will be available online approximately
two weeks before the meeting on the EBMT website: www.ebmt.org.
In addition, copies of the posters will be available on the Cidara
website following the meeting: www.cidara.com.
About Rezafungin
Rezafungin is a novel echinocandin antifungal being developed as a
once-weekly therapy to address significant 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’s Phase 3 ReSTORE
clinical trial for treatment of candidemia and invasive candidiasis is
underway. Cidara anticipates commencing the Phase 3 ReSPECT prophylaxis
clinical trial of rezafungin in patients undergoing allogeneic blood and
marrow transplantation in the first half of 2019, assuming the
successful outcome of ongoing discussions with regulatory authorities.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) represent a serious global health
threat, resulting in more than 1.5 million deaths annually and mortality
rates ranging from 15 to 65 percent. These infections are especially
relevant for patients whose immune systems have been compromised, such
as patients undergoing organ or blood and marrow transplantation or
chemotherapy, including patients with hematologic malignancies. Of the
most significant IFIs, approximately 90 percent of related deaths are
primarily caused by Candida, Aspergillus, and Pneumocystis.
Candida species are most common in hospital-acquired infections,
while Aspergillus species are predominant in patients with
weakened immune systems or lung diseases. Pneumocystis infections
also commonly afflict immunocompromised patients.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel anti-infectives
that have the potential to transform the standard of care and save or
improve patients’ lives. Cidara is currently advancing its novel
echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical
trial, for the treatment of candidemia and invasive candidiasis and
continues to discuss with regulatory authorities its plans for the
design and the initiation of a second Phase 3 trial in the prophylaxis
of invasive fungal infections in patients undergoing allogeneic blood
and marrow transplantation. Rezafungin 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 proprietary Cloudbreak® platform to develop antibody-drug
conjugates (ADCs) for serious viral and bacterial infections, including
further investigation of the high potency and long half-life observed in
its antiviral ADCs for influenza. The Cloudbreak platform is designed to
discover compounds that both directly kill pathogens and direct a
patient’s immune system to attack and eliminate 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, the
potential for rezafungin to provide a simpler dosing regimen and a
potentially superior safety profile compared to current therapies, and
rezafungin’s potential for expanded utility across patient settings.
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/20190307005055/en/
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing
Director
(858) 356-5932
robert.uhl@westwicke.com
MEDIA CONTACT:
Andrea Cohen
Sam Brown Inc.
(917)
209-7163
andreacohen@sambrown.com
