Potent in vitro Activity of SCYNEXIS’ SCY-078 Against Multidrug-Resistant Fungal Pathogen Candida auris Further Confirmed i...
May 11 2017 - 8:30AM
SCY-078 may provide a therapeutic option for this
emerging pathogen classified as a serious global health threat by
the CDC
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today announced the publication
of results of a broad systematic study of the activity of SCY-078
against Candida auris, an emerging life-threatening and
multidrug-resistant fungus, in the Antimicrobial Agents and
Chemotherapy (AAC) medical journal. In this study, the Mycotic
Diseases Branch of the CDC showed that SCY-078, the first
representative of a novel intravenous (IV)/oral triterpenoid
antifungal family, has activity in vitro against C. auris,
confirming SCY-078’s broad spectrum of activity. These results
further build on the evidence previously reported by Case Western
Reserve University School of Medicine and recently published in AAC
regarding the potential for SCY-078 to be active in the treatment
of infections caused by this multidrug-resistant pathogen.
CDC Study Results In this study,
researchers evaluated the in vitro activity of SCY-078 against a
collection of 100 C. auris isolates representing each of the four
known clades of the pathogen and originating from countries all
over the world, including India, Pakistan, Colombia, South Africa,
and the U.S. SCY-078 showed potent activity against all strains at
concentrations indicative of a potentially clinically-relevant
effect. Additionally, the study showed that SCY-078 retained
activity against echinocandin-resistant C. auris isolates,
illustrating that resistance to other glucan synthase inhibitors
(echinocandin class) was not indicative of resistance to
SCY-078.
“Candida auris is an emerging global health threat with an
estimated mortality rate of approximately 60%,” said David Angulo,
M.D., Chief Medical Officer at SCYNEXIS. “Some C. auris strains
have been reported to be resistant to drugs from all commercially
available antifungal classes, underlining the urgent need for
effective new therapies as patients are left without efficacious
treatment options. These initial results are extremely encouraging
and highlight the potential of SCY-078 to address this growing
public health crisis. We look forward to continuing to accelerate
the development of this promising therapy.”
Case Western Reserve University School of
Medicine Study Results The CDC
results reconfirm results published in February by researchers at
Case Western Reserve University School of Medicine who evaluated
the activity of SCY-078 and ten currently available antifungal
agents against 16 different C. auris isolates to determine the
susceptibility of the isolates to these fungal classes. While most
of the assessed strains in this study proved to be resistant to
multiple drugs tested, SCY-078 showed potent activity against all
strains at the concentrations tested. Additionally, results showed
that SCY-078 reduced biofilms and biofilm metabolic activity at all
concentrations tested, a notable feature given C. auris infections
have been frequently associated with IV catheter use.
“These results, taken together, provide further evidence of the
effect SCY-078 may have in the treatment of C. auris
infections, as well as its ability to address other
difficult-to-treat infections in the broader Candida class,” said
Marco Taglietti, M.D., President and Chief Executive Officer of
SCYNEXIS. “This study clearly demonstrates SCY-078’s unique broad
spectrum antifungal activity, a major differentiator over other
available treatments. We believe the key attributes of SCY-078,
including its broad spectrum, activity against resistant strains,
formulation versatility, high tissue distribution, fungicidal
activity and favorable safety profile, will enable the drug to have
a therapeutic effect in a broad variety of serious fungal
infections.”
About Candida auris Candida auris, a
fungal strain first reported in 2009, has been linked to invasive
fungal infections in nine 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 approximately 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.
About SCY-078 SCY-078 is an oral and IV
antifungal agent in Phase 2 clinical development for the treatment
of fungal infections caused
by Candida and Aspergillus species. SCY-078 is
a triterpenoid, semi-synthetic derivative of the natural product
enfumafungin—a structurally distinct and novel class of glucan
synthase inhibitor. SCY-078 combines the well-established activity
of glucan synthase inhibitors (similar to echinocandins) with the
potential flexibility of having IV and oral formulations (similar
to azoles). By belonging to a chemical class distinct from other
antifungals, SCY-078 has shown in vitro and in
vivo activity against multi-drug resistant pathogens,
including azole- and echinocandin-resistant strains. The U.S. Food
and Drug Administration granted Fast Track, Qualified Infectious
Disease Product and Orphan Drug Designations for the oral and IV
formulations of SCY-078 for the indications of invasive candidiasis
(including candidemia) and invasive aspergillosis.
About SCYNEXIS SCYNEXIS, Inc. is a
biotechnology company committed to positively impacting the lives
of patients suffering from difficult-to-treat and often
life-threatening infections by delivering innovative anti-infective
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. The
Company's lead product candidate, SCY-078, is the first
representative of a novel intravenous and oral triterpenoid
antifungal family and is in Phase 2 clinical development for the
treatment of several fungal infections, including serious and
life-threatening invasive fungal infections. For more
information, visit www.scynexis.com.
Forward Looking Statement Statements contained
in this press release maybe, "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. These
risks and uncertainties include, but are not limited, to: risks
inherent in SCYNEXIS' ability to successfully develop SCY-078,
including SCYNEXIS' ability to resolve the FDA's concerns to lift
the clinical hold on the IV formulation of SCY-078 on a timely
basis, if at all, and obtain FDA approval for SCY-078; the
expected costs of studies and when they might begin or be
concluded; and SCYNEXIS' reliance on third parties to conduct
SCYNEXIS' clinical studies. These and other risks are described
more fully in SCYNEXIS' 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:
Media Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
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