JERSEY CITY, N.J., Sept. 4, 2018 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ: SCYX), a biotechnology company delivering innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced the presentation of data at the 2018
European Society of Clinical Microbiology and Infectious Diseases
(ESCMID)/American Society for Microbiology (ASM) Conference on Drug
Development to Meet the Challenge of Antimicrobial Resistance,
September 4-7, 2018, in Lisbon, Portugal. Ibrexafungerp (formerly
SCY-078), 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.
Candida glabrata, the second-most common fungal species
isolated from blood in the US, is one of the most common fungal
pathogens worldwide and fks mutations are a growing problem
leading to echinocandin resistance. The poster presentation,
titled "Ibrexafungerp (formerly SCY-078) Displays Potent In
Vitro Activity Against C. glabrata Isolates with
Mutations in fks Genes," combines the results of several
in vitro studies of ibrexafungerp against a total of 79
Candida glabrata strains with fks mutations showing
that ibrexafungerp maintains potent activity against these
echinocandin-resistant strains when compared to caspofungin and
micafungin.
"With the rapidly rising rates of resistance to many standards
of care available today, including therapies in the azole and
echinocandin classes, the unmet medical need for novel treatment
options for severe fungal infections is growing," said David Angulo, M.D., Chief Medical Officer of
SCYNEXIS. "These data, showing the superior activity of
ibrexafungerp against several echinocandin-resistant strains,
suggest ibrexafungerp has the potential not only to be an effective
treatment option for echinocandin-resistant C. glabrata
strains, but also to play a pivotal role in the broader effort to
develop novel treatment options capable of treating fungal
infections caused by resistant strains."
In five independent studies, the in vitro susceptibility,
determined by broth micro-dilution, of C. glabrata strains
to ibrexafungerp was assessed, including 79 isolates with
fks mutations and 142 wild-type isolates. Comparator
compounds varied across studies and included caspofungin and
micafungin. In these studies, ibrexafungerp demonstrated activity
against 78% of C. glabrata isolates with fks
mutations, including those with the most commonly observed
fks1 and fks2 mutations (S629P and S663P,
respectively), a superior rate as compared to both caspofungin and
micafungin.
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
https://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; anticipated
timing for filing an initial NDA in 2020; plans to start a study in
IA in the third quarter of 2018; 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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SOURCE SCYNEXIS, Inc.