SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that data from studies of its lead antifungal rezafungin will
be presented at the 2019 Transplantation and Cellular Therapy (TCT)
Meeting of ASBMT and CIBMTR (formerly the BMT Tandem Meetings) to be
held in Houston, Texas from February 20-24, 2019.
“The TCT meeting is an important venue for Cidara to share data that
demonstrate the potential advantages of rezafungin for the prevention of
invasive fungal infections in blood and marrow transplant patients,”
said Jeffrey Stein, Ph.D., president and chief executive officer of
Cidara. “We are especially pleased to present new study results
providing further evidence that rezafungin has a low risk of drug-drug
interactions and a favorable tolerability profile as a once-weekly
antifungal prophylactic agent in this vulnerable patient population.”
Invasive fungal infections (IFIs) are a leading cause of morbidity and
mortality among immunocompromised patients, particularly those
undergoing blood and marrow transplantation. Rezafungin is a novel
antifungal echinocandin being developed as a once-weekly therapy for the
prevention of IFIs caused by the most common fungal pathogens: Candida,
Aspergillus and Pneumocystis. No single agent is approved
today to prevent all of these infections, and current prophylaxis
regimens often require multiple antifungals, including azole drugs and
Bactrim, that are associated with known drug-drug interactions as well
as safety and tolerability issues.
The TCT Meeting convenes more than 3,700 attendees to present and
discuss recent progress in basic science, translational research and
clinical studies in all areas of blood and marrow transplantation and
cellular therapy. Rezafungin data will be featured in three poster
presentations by Cidara Therapeutics and its collaborators during Poster
Session II, taking place on Saturday, February 23, 2019 from 6:45 p.m. –
7:45 p.m. (Central Time) at the George R. Brown Convention Center, Level
3, Hall B. Presentation details are as follows:
Title: No Relevant Pharmacokinetic (PK) Interaction between Rezafungin
and Nine Probe Drugs: Results from a Drug-Drug Interaction (DDI) Study
Poster
Number: 535
Presenter: V. Ong
Title: Pharmacokinetic-Pharmacodynamic Analyses of Dose Selection for
Rezafungin Prophylaxis Against Invasive Fungal Infections in Bone Marrow
Transplantation
Poster Number: 537
Presenter: W. Brown
Title: Rezafungin Prophylactic Efficacy in a Mouse Model of Pneumocystis
Pneumonia
Poster Number: 549
Presenter: M. Cushion
All three posters will be on display from 9:00 a.m. until 5:00 p.m.
(Central Time) on Saturday, February 23. 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 and Cidara plans to commence the Phase 3 ReSPECT prophylaxis
clinical trial of rezafungin in patients undergoing allogeneic blood and
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. Approximately 90 percent of all reported fungal
related deaths result from a few common fungi, including Candida,
Aspergillus and Pneumocystis. Systemic fungal infections
typically affect patients whose immune systems have been compromised,
such as the severely ill and those undergoing organ or blood and marrow
transplantation or chemotherapy, including patients with hematologic
malignancies.
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 in patients undergoing
allogeneic blood and marrow transplants. 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
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/20190205005231/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
