Skip to main content
Press Releases

FDA Grants QIDP and Fast Track Designations to Cidara Therapeutics’ Rezafungin Prophylaxis Development Program

By September 25, 2018No Comments

Rezafungin designated for the prevention of invasive fungal
infections in adults undergoing bone marrow transplantation

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that the U.S. Food and Drug Administration (FDA) has granted
both Qualified Infectious Disease Product (QIDP) and Fast Track
designations for the company’s prophylaxis (prevention) development
program for lead antifungal product candidate, rezafungin for injection.
Specifically, the QIDP designation is for the development of rezafungin
for the prevention of invasive fungal infections in adults undergoing
allogeneic bone marrow transplantation. Cidara previously announced QIDP
designation for rezafungin for the treatment of invasive fungal
infections caused by Candida.

“This important FDA designation provides significant support for the
development of rezafungin in the hematology setting,” said Jeffrey
Stein, Ph.D., president and chief executive officer of Cidara. “We now
have the opportunity to expedite the development of rezafungin to
address significant unmet needs both in the prevention of invasive
fungal infections in immunocompromised patients undergoing bone marrow
transplantation, as well as for the treatment of patients with existing
severe invasive fungal infections.”

Cidara is developing rezafungin, a novel antifungal echinocandin, as a
once-weekly, high-exposure therapy for the treatment and prevention of
serious invasive fungal infections. Rezafungin is being studied to
address unmet needs in the treatment of candidemia and invasive
candidiasis as well as for prophylaxis of invasive fungal infections due
to common fungal pathogens: Candida, Aspergillus and Pneumocystis.
No one agent is approved today to prevent infections caused by these
pathogens and current prophylaxis regimens often require multiple
antifungal drugs with safety and tolerability issues. Cidara plans to
commence the Phase 3 ReSPECT prophylaxis clinical trial of rezafungin in
patients undergoing allogeneic bone marrow transplantation in the first
quarter of 2019.

The QIDP designation, provided under the Generating Antibiotic
Incentives Now Act (GAIN Act), offers certain incentives for the
development of new antifungal and antibacterial drugs, including Fast
Track, priority review and, if rezafungin is ultimately approved by the
FDA, eligibility for an additional five years of marketing exclusivity.
Fast Track designation enables more frequent interactions with the FDA
review team to expedite drug development.

To achieve QIDP designation, a drug candidate must be intended to treat
serious or life-threatening infections, particularly those caused by
bacteria and fungi that are resistant to treatment, or that treat
qualifying resistant pathogens identified by the FDA. These listed
qualified pathogens include Candida and Aspergillus
species, which have the potential to pose a serious threat to public

About Invasive Fungal Infections

Approximately 97,000 Americans die from hospital-related invasive fungal
infections each year and 90 percent of these infections are caused by
two common fungi, Candida and Aspergillus. Pneumocystis
Pneumonia (PCP) is another serious fungal infection that commonly
afflicts people with weakened immune systems. Systemic fungal infections
typically affect patients whose immune systems have been compromised,
such as patients undergoing organ or bone marrow transplantation or
chemotherapy, including patients with hematologic malignancies, or
patients in intensive care units and those with prolonged hospital stays.

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,
formerly known as CD101 IV, through clinical trials. 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. The company’s
Phase 2 STRIVE clinical trial of rezafungin met its primary safety and
efficacy objectives, and provides support for Cidara to initiate Phase 3
pivotal trials in the treatment of candidemia and invasive candidiasis
and the prophylaxis of invasive fungal infections. Cidara is also
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

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 impact of the QIDP and Fast Track
designations on our rezafungin development program, 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

Cidara Therapeutics, Inc.
Partners, LLC
Robert H. Uhl
Managing Director

Sam Brown Inc.
Christy Curran