SCYNEXIS Presents New Data Further Supporting SCY-078 as a Potential Treatment for Aspergillus and Candida Infections at IDWe...
October 05 2017 - 8:30AM
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today presented new data for
SCY-078, the Company’s lead product candidate, at IDWeek 2017,
October 4-8, 2017 in San Diego, CA. SCY-078 is the first
representative of a novel oral and intravenous (IV) triterpenoid
antifungal family in clinical development for the treatment of
several fungal infections, including invasive candidiasis, invasive
aspergillosis and vulvovaginal candidiasis.
“The data presented at IDWeek demonstrate the broad activity and
potential clinical utility of SCY-078 against invasive Candida and
Aspergillus infections as well as the significant tissue
distribution of oral and IV SCY-078,” said David Angulo, M.D.,
Chief Medical Officer of SCYNEXIS. “These results further support
our ongoing clinical development of SCY-078 and broaden its
potential applicability for multiple fungal infections, including
those infections that are invasive and treatment-resistant.”
“The increasing rates of resistance observed in Candida and
Aspergillus species to available therapies create an urgent need
for novel antifungal agents,” said Marco Taglietti, M.D., President
and Chief Executive Officer of SCYNEXIS. “These results reinforce
the potency of the SCY-078 platform and emphasize our strong
commitment to advancing the development of SCY-078 as quickly as
possible so that patients struggling with these severe infections
have viable treatment options.”
SCY-078 Shows Potent Activity Against Invasive
Aspergillus (IA)The first poster, “SCY-078 Demonstrates
Significant Antifungal Activity in a Murine Model of Invasive
Aspergillosis,” details results of a study designed to evaluate the
in vivo antifungal activity of oral SCY-078 in a neutropenic murine
model of IA. SCY-078 demonstrated potent activity against wild-type
(WT) and azole-resistant strains of A. fumigatus, achieving the
primary endpoint of survival at day 14 as well as secondary
endpoints of change in fungal kidney burden and serum galactomannan
index. These encouraging results support the continued development
of oral SCY-078 as a treatment for Aspergillus infections.
SCY-078 Shows Compelling Activity Against WT,
Azole-Resistant and Echinocandin-Resistant C. parapsilosis
StrainsThe second poster, “Assessment of the In
Vitro Antifungal Activity of SCY-078 Against a Collection
of Candida parapsilosis Clinical Isolates,” details
results of a study designed to evaluate the in vitro antifungal
activity of SCY-078 against a collection of 206 clinical C.
parapsilosis isolates. SCY-078 demonstrated significant activity,
as measured by minimum inhibitory concentrations (MIC), against C.
parapsilosis isolates, including WT, azole-resistant and
echinocandin-resistant strains.
SCY-078 Shows Significant Tissue Penetration Following
Oral or IV AdministrationThe third poster, “SCY-078
Demonstrates Significant Tissue Penetration in Rats and Mice
Following Oral or IV Administration,” details results of
several studies designed to evaluate tissue distribution of SCY-078
in rats and mice following oral or IV administration. In both
models, SCY-078 demonstrated significant tissue penetration at
clinically meaningful levels in various target organs.
Specifically, the concentrations observed in lung, vaginal tissue
and kidney, among other tissues, exceeded the plasma concentrations
several fold. These results reinforce the potential therapeutic
benefit of orally and intravenously administered SCY-078 for both
treatment and prophylaxis of invasive fungal infections.
All presentations are available on the Scientific Publications
page of the SCYNEXIS website.
About SCY-078 SCY-078 is an 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 with the potential flexibility of
having IV and oral formulations. 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 formulations of SCY-078 for the indications of
invasive candidiasis (including candidemia) and invasive
aspergillosis.
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 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
RelationsCammy DuongMacDougall Biomedical
CommunicationsTel: 781-591-3443cduong@macbiocom.com
Investor
RelationsSusan KimArgot PartnersTel:
212-203-4433susan@argotpartners.com
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