New Study Further Demonstrates In Vitro Activity of SCYNEXIS’ Lead Anti-Infective Candidate, SCY-078, Against Drug-Resistan...
15 June 2017 - 10:30PM
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 from a study evaluating the activity of SCY-078 against
three hundred and fifty-one Candida clinical isolates from eleven
different species, including forty-four echinocandin-resistant
strains. In this study, published in the Antimicrobial Agents and
Chemotherapy (AAC) medical journal, researchers determined that
SCY-078, the first representative of a novel intravenous (IV)/oral
triterpenoid antifungal family, has potent in vitro activity
against a range of Candida species, including
echinocandin-resistant strains, demonstrating SCY-078’s broad
spectrum of activity.
“With the growing emergence of non-albicans Candida
and antifungal resistance seen in hospitals in the United States,
Europe and Asia, it is clear that exposure to azoles and
echinocandins is resulting in a rise in these invasive and
treatment-resistant fungal infections,” said David Angulo, M.D.,
Chief Medical Officer of SCYNEXIS. “These results support SCY-078’s
broad spectrum of activity against medically relevant Candida spp.
including isolates carrying FKS gene mutations, that decrease
sensitivity to current front-line therapies. These findings
suggest that SCY-078 may prove to be an effective treatment
strategy for Candida infections associated with prior treatment
failure and high mortality rates.”
In the study, “Differential Activity of the Oral
Glucan Synthase Inhibitor SCY-078 against Wild-Type (WT) and
Echinocandin-Resistant Strains of Candida spp.,” researchers
evaluated the in vitro activity of SCY-078 against three hundred
and fifty-one WT and echinocandin-resistant isolates of eleven
species of Candida. The study illustrated SCY-078’s potent activity
across a broad range of fungal strains at concentrations indicative
of a potentially clinically-relevant effect. Specifically, among C.
glabrata isolates carrying FKS alterations, 84% were non-WT to the
echinocandins compared with only 24% for SCY-078. In contrast to
echinocandin comparators, the activity of SCY-078 was minimally
affected by the presence of FKS mutations suggesting that SCY-078
may be useful in the treatment of Candida infections, particularly
echinocandin-resistant strains.
“These data showcase SCY-078’s broad spectrum of
activity across a range of Candida isolates, further supporting our
commitment to the development of this novel anti-infective and its
potential to impact how life-threatening infections are treated,”
said Marco Taglietti, M.D., President and Chief Executive Officer
of SCYNEXIS. “Given that echinocandin treatment is only available
in an IV formulation, the addition of an agent like SCY-078,
potentially available both orally and intravenously, for
therapeutic protocols could serve to reduce prolonged hospital
stays for patients undergoing anti-fungal therapy.”
About SCY-078 SCY-078 is an oral
and IV antifungal agent in 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
Invasive Candida Infections Invasive candidiasis
is a serious, often life-threatening infection caused
by Candida species that typically affects a highly
vulnerable population such as immunocompromised patients or
patients under intensive care in hospital settings. The U.S.
annual incidence is estimated to be approximately 100,000 cases
with high mortality rates (i.e., 20-40%) despite currently
available antifungal agents. Furthermore, the limited number of
antifungal drug classes, consisting of azoles, echinocandins and
polyenes, and their widespread use, has led to increased numbers of
candida infections with drug-resistant strains. The Centers for
Disease Control has listed
fluconazole-resistant Candida as a serious public health
threat requiring prompt and sustained action.
About SCYNEXISSCYNEXIS, 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 may be, "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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