FDA Grants QIDP and Fast Track Designations to Cidara Therapeutics’ Rezafungin Prophylaxis Development Program
September 25 2018 - 8:00AM
Business Wire
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 health.
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 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 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
made.
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Cidara Therapeutics, Inc.INVESTOR CONTACT:Westwicke
Partners, LLCRobert H. UhlManaging
Director858-356-5932robert.uhl@westwicke.comorMEDIA
CONTACT:Sam Brown Inc.Christy
Curran615-414-8668ChristyCurran@sambrown.com
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