Cidara Therapeutics Initiates Phase 1 Study of Lead Antifungal Product Candidate CD101 IV

SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives and immunotherapies to treat fungal and
other infections, today announced the initiation of a Phase 1,
randomized, double-blind, dose-escalation study to determine the safety,
tolerability, and pharmacokinetics of CD101 IV in healthy subjects.

“The advancement of our first product candidate into the clinic ahead of
schedule is a significant next step toward our mission to address the
urgent need for effective new antifungal treatments,” said Jeffrey
Stein, Ph.D., president and chief executive officer of Cidara. “CD101 IV
is a novel, long-acting antifungal that could ultimately provide
physicians with a new treatment option for their patients fighting
serious, life-threatening fungal infections.”

Cidara is developing CD101 IV, an agent in the echinocandin class of
antifungals, for the treatment and prevention of systemic Candida
infections, including candidemia and related cases of invasive
candidiasis. Systemic fungal infections are associated with high
mortality rates and typically affect patients whose immune systems have
been compromised, such as patients undergoing organ or bone marrow
transplantation, chemotherapy, and many patients in ICUs.

“Even with the current armamentarium of antifungals, the mortality rate
of candidemia is still 35 percent,” said Pete Pappas, M.D., professor of
medicine in the Division of Infectious Diseases at the University of
Alabama in Birmingham. “Candida resistance to the standard
classes of therapies is rising, increasing the need for new antifungal
agents, yet it has been almost a decade since the last agent was
approved for candidemia, which leaves physicians with few viable options
for patients.”

The U.S. Food and Drug Administration (FDA) has designated CD101 IV as a
Qualified Infectious Disease Product (QIDP) with Fast Track status. The
QIDP and Fast Track designations are for the use of CD101 IV in the
treatment of candidemia and invasive candidiasis.

More information about this trial will be available soon at
ClinicalTrials.gov.

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, for the
treatment of serious fungal infections. CD101 IV is a long-acting
therapy for the treatment and prevention of systemic fungal infections,
and CD101 topical is for the treatment of vulvovaginal candidiasis (VVC)
and 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.

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 and long-acting nature of
CD101 IV and 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 documents most
recently filed with the United States Securities and Exchange Commission
(SEC), including its Registration Statement on Form S-1 declared
effective by the SEC on April 14, 2015, under the heading “Risk
Factors.” 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.

Contacts

Sam Brown Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com

Powered by WPeMatico