JERSEY CITY, N.J.,
Oct. 15, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ:
SCYX), a biotechnology company delivering innovative therapies for
difficult-to-treat and often life-threatening infections, today
announced the dosing of the first patient with a Candida
auris infection, an emerging life-threatening and
multidrug-resistant fungal pathogen, in a Phase 3 open-label study
evaluating oral ibrexafungerp (formerly SCY-078) in patients with
candidiasis caused by C. auris (the CARES Study).
Ibrexafungerp, the first representative of a novel oral and
intravenous (IV) triterpenoid antifungal family, is in clinical
development for the treatment of multiple serious fungal
infections, including vulvovaginal candidiasis (VVC), invasive
candidiasis (IC), invasive aspergillosis (IA) and refractory
invasive fungal infections.
The CARES study is a multi-center (U.S. and India), open-label, single-arm study designed
to evaluate the efficacy, safety and tolerability of oral
ibrexafungerp in subjects with documented C. auris
infections (Clinicaltrials.gov NCT03363841).
"The need for effective new therapies for C.
auris infections is clear, as the mortality rate for those
infected is up to 60% and many strains have been reported to be
resistant to drugs from all commercially available antifungal
classes," said David Angulo, M.D.,
Chief Medical Officer of SCYNEXIS. "Ibrexafungerp has shown potent
in vitro activity against C. auris, including in
strains resistant to other antifungal agents, and we are committed
to evaluating its potential to serve as a therapy for patients
affected by this difficult-to-treat infection. We thank the
investigators for their participation in the CARES study, and we
look forward to advancing this important trial."
To date, SCYNEXIS has reported the results of multiple
pre-clinical studies demonstrating the potent activity of
ibrexafungerp against C. auris:
- Centers for Disease Control (CDC) Study, reported in the
Antimicrobial Agents and Chemotherapy (AAC) medical journal,
evaluated the in vitro activity of ibrexafungerp against a
collection of 100 C. auris isolates. Ibrexafungerp showed
potent activity against all strains at concentrations similar to
clinically relevant doses. Additionally, the study showed that
ibrexafungerp retained similar activity against both susceptible
and multidrug-resistant strains, including echinocandin-resistant
C. auris isolates.
- Case Western Reserve University
School of Medicine Study, reported in the AAC medical
journal, characterized the activity of ibrexafungerp, demonstrating
potent activity against all tested C. auris isolates.
Additionally, results showed that ibrexafungerp reduced biofilms
and biofilm metabolic activity, a notable feature as C.
auris infections have been frequently associated with
intravenous catheter use.
About Candida auris
Candida
auris, a fungal strain first reported in 2009, has been linked
to invasive fungal infections in several countries, including the
U.S., and has caused at least two hospital outbreaks involving more
than 30 patients each. The CDC estimates that infections
with C. auris are associated with a mortality rate
of up to 60% and that some strains of this species
of Candida have proven to be resistant to all
three major classes of antifungal drugs, rendering treatment
difficult. This type of broad resistance to approved antifungal
agents has not been observed in other species
of Candida. The most common type of infection caused
by C. auris is in the bloodstream. The CDC is
actively tracking C. auris infections globally and
has issued an alert to all healthcare facilities classifying this
new pathogen as a serious global health threat. The incidence
of C. auris infections in the U.S. is rapidly
growing; in just the past year, the number of confirmed cases
reported by the CDC has more than doubled.
For more information about C. auris, visit:
https://www.cdc.gov/fungal/candida-auris/index.html
About Ibrexafungerp (formerly SCY-078)
Ibrexafungerp
[pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal
agent and the first representative of a novel class of
structurally-distinct glucan synthase inhibitors, triterpenoids.
This agent combines the well-established activity of glucan
synthase inhibitors with the potential flexibility of having oral
and IV formulations. Ibrexafungerp is currently in development for
the treatment of fungal infections caused primarily
by Candida (including C. auris)
and Aspergillus species. It has demonstrated broad
spectrum antifungal
activity, in vitro and in vivo,
against multidrug-resistant pathogens, including azole- and
echinocandin-resistant strains. The FDA has granted QIDP and Fast
Track designations for the formulations of ibrexafungerp for the
indications of IC (including candidemia), IA and VVC, and has
granted Orphan Drug Designation for the IC and IA indications.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ:SCYX) is a
biotechnology company committed to positively impacting the lives
of patients suffering from difficult-to-treat and often
life-threatening infections by developing innovative therapies. The
SCYNEXIS team has extensive experience in the life sciences
industry, discovering and developing more than 30 innovative
medicines over a broad range of therapeutic areas. SCYNEXIS's lead
product candidate, ibrexafungerp (formerly SCY-078), is a novel
oral/IV antifungal agent in Phase 2 clinical and pre-clinical
development for the treatment of multiple serious and
life-threatening invasive fungal infections caused by Candida and
Aspergillus species. For more information, visit
www.scynexis.com.
Forward Looking Statement
Statements contained in this
press release regarding expected future events or results are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including without
limitation, statements regarding: expectations for the timing
of initiation of, and dosing in, clinical trials; plans for review
of FURI and CARES. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited, to: risks
inherent in SCYNEXIS's ability to successfully develop
and obtain FDA approval for ibrexafungerp; the expected
costs of studies and when they might begin or be concluded; and
SCYNEXIS's reliance on third parties to
conduct SCYNEXIS's clinical studies and to manufacture
product supplies. These and other risks are described more fully
in SCYNEXIS's filings with the Securities and
Exchange Commission, including without limitation, its most recent
Annual Report on Form 10-K under the caption "Risk Factors" and
other documents subsequently filed with or furnished to
the Securities and Exchange Commission. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. SCYNEXIS undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were
made.
CONTACT:
Investor Relations
Natalie
Wildenradt
Argot Partners
Tel: 212-600-1902
natalie@argotpartners.com
Media Relations
George E.
MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com
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