JERSEY CITY, N.J., July 18, 2018 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ: SCYX), a biotechnology company delivering innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced that the World Health Organization's
(WHO) International Non-proprietary Name (INN) group has assigned
the generic name "ibrexafungerp" [pronounced
eye-BREX-ah-FUN-jerp] for its lead candidate SCY-078, the first
representative of a novel oral and intravenous (IV) triterpenoid
antifungal family. SCYNEXIS is developing ibrexafungerp for the
treatment of multiple serious fungal infections, including
vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive
aspergillosis (IA) and refractory invasive fungal infections.
"The WHO's assignment of ibrexafungerp as the generic name for
SCY-078 is a significant accomplishment for SCYNEXIS, as this name
incorporates a novel stem for our antifungal platform and marks
SCY-078 as the first member of a new class of drugs for the
treatment of serious fungal infections," said Marco Taglietti, M.D., President and Chief
Executive Officer of SCYNEXIS. "For nearly two decades, only three
drug classes have encompassed all FDA-approved antifungal
treatments. Ibrexafungerp has the potential to represent the first
new antifungal class approved since 2001, providing unique benefits
of critical importance given the rapidly rising rates of antifungal
resistance to many standard of care therapies."
The INN system was established to facilitate the identification
of pharmaceutical substances or active pharmaceutical ingredients
in a unique, globally-recognized manner. Obtaining a
non-proprietary, or generic, name is a required step in bringing a
new drug to market. Generic names of pharmacologically-related
substances demonstrate their relationship by using a common "stem,"
allowing medical practitioners and pharmacists to recognize
substances having similar pharmacological activity. This is
important for the clear identification, safe prescription and
dispensing of medicines to patients. The generic name ibrexafungerp
includes a new stem, "-fungerp," which indicates that SCY-078 is
unlike any previously-approved drug, and reflects its
first-in-class nature.
"We are progressing preclinical screening of additional members
of the 'fungerp' family as we seek to expand our portfolio of
assets and maximize the potential clinical utility of this new
family of compounds," said David
Angulo, M.D., Chief Medical Officer of SCYNEXIS. "We also
continue to progress the development of our lead compound,
ibrexafungerp, in multiple serious indications, building on the
recent positive results of oral ibrexafungerp in our Phase
2b DOVE study for VVC."
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 U.S. Food and Drug Administration (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 IV/oral antifungal agent in Phase 2
clinical and preclinical 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. 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. 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.