Cidara Therapeutics Reports Unfavorable Results of Phase 2 RADIANT Trial of CD101 Topical in VVC
February 21 2017 - 7:30AM
Further Development of CD101 Topical for
VVC to be discontinued
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
reported that the randomized, controlled Phase 2 RADIANT clinical
trial in acute vulvovaginal candidiasis (VVC) did not show
sufficient efficacy to justify further development of the tested
topical formulations. RADIANT was designed to evaluate gel and
ointment topical formulations of the novel echinocandin antifungal
CD101 in women with moderate-to-severe acute VVC.
The study found that the gel and ointment topical formulations
of CD101 evaluated in RADIANT were similar in efficacy to each
other but lower in clinical and mycological cure rates compared to
oral fluconazole.
“We are obviously disappointed with these results, which did not
demonstrate the highly potent antifungal properties of CD101
against Candida we saw in preclinical animal models of VVC. While
we believe that an improved topical formulation of CD101 could
improve outcomes, at this time we have no plans for further
development of CD101 topical in VVC,” said Jeffrey Stein, Ph.D.,
president and chief executive officer of Cidara. “We would like to
thank the investigators and the patients who participated in this
trial. This does not impact our development of CD101 IV for the
treatment of candidemia and invasive candidiasis, for which animal
models are well established and highly predictive of clinical
outcomes.”
The discontinuation of the CD101 topical development program for
VVC will enable Cidara to shift resources to other promising
product candidates currently in its portfolio, including CD101 IV,
currently being studied in Phase 2 for candidemia, and the
expansion and acceleration of the Cloudbreak immunotherapy
platform, including CD201 for the treatment of infections caused by
multi-drug resistant Gram-negative bacteria.
RADIANT was a multicenter, randomized, open-label,
active-controlled, dose-ranging trial that enrolled 125 patients
into three treatment cohorts. In the first cohort, 50 patients were
treated with CD101 Gel; a second cohort of 50 patients was treated
with CD101 Ointment. The third cohort comprised 25 patients treated
with oral fluconazole. The trial included women with and without a
history of recurrent VVC (RVVC). A table of topline results is
included below.
Topline Key Clinical and Microbiological Cure Rates in
the mITT* Population
|
CD101 Topical Gel (n=40) |
CD101 Topical Ointment (n=40) |
Fluconazole (n=19) |
Clinical Cure Day 7 (Cure defined as VSS**=0) |
37.5 |
% |
40.0 |
% |
47.4 |
% |
Clinical Cure Day 7 (Cure defined as VSS**≤ 2) |
57.5 |
% |
62.5 |
% |
78.9 |
% |
Mycologic Cure Day 28 |
45.0 |
% |
40.0 |
% |
57.9 |
% |
*mITT population: Subjects who received at least one dose of
study drug with a positive vaginal culture for Candida species and
no coinfection with other vaginal or cervical infections at
screening.**Vaginal Scoring System (VSS): a scale used to determine
VVC severity based on a scale of 0 (absent) to 3 (severe) for each
of 6 signs and symptoms for a maximum score of 18.
CD101 Gel and Ointment were well-tolerated. The number of
patients with at least one treatment emergent adverse event (TEAE)
considered related to study drug by the investigator were two, four
and zero in the CD101 Gel, CD101 Ointment and fluconazole arms,
respectively. There were no serious adverse events reported
in any treatment arm.
About CD101 IV
CD101 IV has enhanced potency and is the only once-weekly
therapy intended for the treatment and prevention of
life-threatening invasive fungal infections. Cidara’s
international Phase 2 clinical trial of CD101 IV in candidemia, the
STRIVE trial, remains on track. The STRIVE trial is a double-blind
trial comparing the safety and efficacy of once weekly CD101 IV to
standard-of-care therapy, caspofungin, with an optional step-down
to oral fluconazole. As primary endpoints, the trial will measure
mycological eradication and resolution of systemic signs
attributable to candidemia at day 14. Results from this trial are
expected during the fourth quarter of 2017.
Conference Call and Webcast
Management will host a conference call and webcast at 8.30 a.m.
EST/5:30 a.m. PST today. To participate in the conference call by
telephone, please dial 844-358-8763 for domestic callers, or
703-736-7375 for international callers, and use the conference ID #
75165690. The webcast will be made available on Cidara’s website at
www.cidara.com under the Investors tab in the Events section.
Following the live audio webcast, a replay will be available on
Cidara's website for approximately 30 days.
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,
CD101 IV, through Phase 2 and developing CD201, its bispecific
antimicrobial immunotherapy, for the treatment of multi-drug
resistant Gram-negative bacterial infections. CD101 IV has enhanced
potency and is the only once-weekly therapy intended 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
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 related to
the progress and timing of Cidara’s drug discovery and development
programs, including the application of additional resources to the
CD101 IV and Cloudbreak programs; the potential for CD101 IV to be
a safe and effective treatment option for serious invasive fungal
infections; and the potential for CD201 to be a safe and effective
treatment option for infections caused by multi-drug resistant Gram
negative bacteria. 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. 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
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