Results from Multiple Dose Phase 1 Trial of CD101 IV Supporting
High-Exposure, Once-Weekly Dosing Will Be Presented For the First Time
SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives and immunotherapies to treat fungal and
other infections, today announced that data from preclinical and
clinical studies evaluating its lead antifungal product candidate,
CD101, will be presented at the American Society for Microbiology (ASM)
Microbe 2016 meeting in Boston from June 16-20.
In total, four oral and two poster presentations regarding Cidara’s
novel echinocandin CD101 have been accepted for presentation. They
include a late-breaker poster presentation on the successful Phase 1
multiple ascending-dose clinical trial of CD101 IV, representing the
first time these results will be presented at a medical meeting. The
data to be presented support the continued development of CD101 IV as a
once-weekly, high-exposure echinocandin. Additional data to be presented
at ASM Microbe build on Cidara’s understanding of the clinical profile
of CD101 and reinforce its commitment to addressing significant unmet
medical needs for new antifungals to treat serious fungal infections.
“The scope of data to be presented at ASM Microbe 2016 underscore
Cidara’s commitment to pursuing novel antifungal therapies,” said
Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
“We and our scientific collaborators look forward to sharing the latest
results from our ongoing clinical research on CD101, which highlight the
efficacy, safety and versatility of this compound as well as the rapid
progress we’ve made with our development programs for CD101 IV and
topical.”
The ASM Microbe 2016 presentations are:
Oral Presentations:
Friday, June 17: Session 016 – New Antifungals (8:15 a.m. – 10:45
a.m. ET, Westin, Marina Ballroom III)
-
Optimization of CD101 Formulation Against Candida albicans in a
Rat Model of Vulvovaginal Candidiasis; V. Ong, et. al. (8:15 a.m.) -
Prevention of Pneumocystis Pneumonia by the Long Acting Echinocandin
CD101; M.T. Cushion, et. al. (8:30 a.m.) -
Efficacy of a Novel Echinocandin, CD101, in a Mouse Model of
Azole-Resistant Disseminated Candidiasis; L. Miesel, et. al. (8:45
a.m.)
Sunday, June 19: Session 247 – Innovations and Challenges in
Pharmacokinetics/Pharmacodynamics (PK/PD) (8:15 a.m. – 10:45 a.m. ET,
BCEC, Meeting Room 156A)
-
Tissue Distribution and Pharmacokinetics of CD101 in an
Immunocompetent Mouse Model of Invasive Candidiasis; Y. Zhao,
D. S. Perlin, et. al. (9:00 a.m.)
Poster Presentations:
Saturday, June 18: Session 150 – Late-Breaker Poster Presentations
(12:45 p.m. – 2:45 p.m. ET, Exhibit and Poster Hall, Halls A and B)
-
LB-057: Safety and Pharmacokinetics of
Multiple Doses of CD101 Injection: Results from a Phase 1,
Dose-escalation Study; T. Sandison, et. al.
Sunday, June 19: Session 309 – Pre-Clinical
Pharmacokinetic/Pharmacodynamic (PK/PD) (12:30 p.m. – 2:30 p.m.,
ET, BCEC, Exhibit and Poster Hall, Halls A and B)
-
*SUNDAY-505: Pharmacological Basis of
CD101 Efficacy: Exposure Shape Matters; E. A. Lakota, P.
G. Ambrose, et. al.
*This poster will be showcased during the Poster Walk on Sunday, June 19
from 12:30 p.m. – 1:30 p.m., ET, in Hall A, which will include a 3-5
minute live summary of the poster followed by a brief question and
answer period.
Copies of these posters will be available on the Cidara website
following the ASM Microbe 2016 meeting: http://www.Cidara.com/
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel anti-infectives
for the treatment of diseases that are inadequately addressed by current
standard-of-care therapies. Cidara’s initial product portfolio comprises
two formulations of the company’s novel echinocandin, CD101. CD101 IV is
being developed as a once-weekly, high-exposure therapy for the
treatment and prevention of serious, invasive fungal infections. CD101
topical is being developed for the treatment of vulvovaginal candidiasis
(VVC) and the prevention of recurrent VVC (RVVC), a prevalent mucosal
infection. In addition, Cidara has developed a proprietary immunotherapy
platform, Cloudbreak™, designed to create compounds that direct a
patient’s immune cells to attack and eliminate pathogens that cause
infectious disease. 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 effectiveness, safety, long-acting nature,
anticipated human dosing and other attributes of CD101 IV and CD101
topical, and their potential to treat infections, as well as the
intended design of current and future Cloudbreak™ compounds. 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: http://www.businesswire.com/news/home/20160608005444/en/
Investor:
Westwicke Partners, LLC
Robert H. Uhl,
858-356-5932
Managing Director
robert.uhl@westwicke.com
or
Media:
Sam
Brown Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com
