JERSEY CITY, N.J., June 27, 2018 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ:SCYX), a biotechnology company developing innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced the presentation of data at the
Teratology Society 58th Annual Meeting, June 23-27, 2018 in Clearwater, Florida. 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.
"The treatment of fungal infections during pregnancy has long
been challenging due to the well-known developmental toxicities
associated with existing antifungal treatments," said David Angulo, M.D., Chief Medical Officer of
SCYNEXIS. "These studies provide evidence that SCY-078 does not
exhibit developmental or reproductive toxicity when administered to
animals before and/or during gestation. The absence of
teratogenicity is a critical differentiator for SCY-078, as the
majority of currently available antifungal therapies, including
azoles, are associated with fertility and early embryonic
development toxicities."
The poster, titled "SCY-078, a Novel IV/Oral Triterpenoid
Antifungal Treatment, is Not Embryo/Feto-toxic,"
describes the results of pre-clinical studies designed to assess
the impact of SCY-078 on reproductive potential, mating behavior,
and embryonic and fetal development. To assess the impact on
reproductive potential, SCY-078 was administered to Wistar rats
prior to and during mating; then continuously through early
gestation to assess the impact on early pregnancy and to the
conceptus. Additionally, to assess the impact of SCY-078 on
the embryo-fetal development, SCY-078 was administered to Wistar
rats and Dutch-belted rabbits throughout the period of
organogenesis. At doses greater than the efficacious clinical
exposure, sexual function, maturation of gametes, estrous cycles,
pregnancy rates and implantation were comparable to vehicle
control; rats and rabbits receiving oral SCY-078 showed no enhanced
toxicities relative to those noted in studies conducted with
non-pregnant females, there was no increase in embryo-fetal loss,
and evaluations of fetal development revealed no SCY-078-related
anomalies in the rats or rabbits.
"These results represent an important positive first step in
determining the safety of SCY-078 use during pregnancy, a critical
aspect for female patients and their physicians," said Marco Taglietti, M.D., President and Chief
Executive Officer of SCYNEXIS. "Oral fluconazole, the standard of
care for VVC, has warnings when used by pregnant women or women in
child-bearing age, in whom VVC infections occur more frequently. We
are extremely encouraged by these results as we continue to work
toward advancing the development of oral SCY-078 in VVC and other
indications, including reporting the topline results from our Phase
2b DOVE study by July 2018."
The poster is available on the Scientific
Publications page of the SCYNEXIS website.
About the DOVE Study
The Phase 2b study is a randomized, multi-center,
double-blind, active-controlled, dose-finding study designed to
evaluate the safety, efficacy, tolerability and pharmacokinetics of
oral SCY-078 compared to oral fluconazole in adult, female patients
with moderate to severe acute VVC. A total of 186 patients were
randomized to one of five different dosing regimens of oral SCY-078
or oral fluconazole, the current standard of care treatment for
VVC. The primary objective of the study is to identify the
recommended dose of oral SCY-078 to be used in the Phase 3 clinical
program. The primary endpoint of the study is efficacy as measured
by the percentage of patients with clinical cure, defined as
complete resolution of signs and symptoms, at the test-of-cure
visit (Day 10). Secondary endpoints, such as clinical cure rate at
the follow-up visit (Day 25) and mycological eradication (negative
fungal culture) at both time points, will also be evaluated.
About Vulvovaginal Candidiasis
VVC, commonly known as
a "vaginal yeast infection," is the second most common cause of
vaginitis and is usually caused by Candida spp.
VVC can be associated with substantial morbidity, including
significant genital discomfort, reduced sexual pleasure,
psychological distress and loss of productivity. Typical VVC
symptoms include pruritus, vaginal soreness, irritation and
abnormal vaginal discharge. An estimated 70-75% of women worldwide
will have at least one episode of VVC in their lifetime, and
40%-50% of them will experience two or more episodes. As many as 8%
of the women with VVC suffer from recurrent disease, defined as
experiencing at least four episodes within a 12-month period.
VVC episodes include the following:
- Uncomplicated cases. These are sporadic mild-to-moderate
infections typically caused by C. albicans spp. in
a normal host. They represent the majority of the VVC episodes;
and
- Complicated cases. These represent the remaining
episodes and include: severe infections, recurrent cases,
infections caused by non-albicans Candida spp., and/or
observed in an abnormal host.
Current treatments for acute VVC include over-the-counter (OTC)
topical azole antifungals (clotrimazole, miconazole, and others)
and the use of the prescription oral azole antifungal, fluconazole.
Fluconazole is the only orally-administered antifungal currently
approved for acute VVC in the U.S., with a therapeutic cure rate of
55% as reported in its label. Uncomplicated acute VVC
cases are often effectively treated with topical agents and/or with
one to three doses of oral fluconazole. However,
management of VVC during pregnancy, moderate-to-severe VVC,
recurrent VVC and VVC caused by
fluconazole-resistant Candida spp., are not fully
addressed by oral fluconazole. In addition, there are no oral
alternatives for VVC patients who do not respond to or tolerate
fluconazole, and there are no U.S. Food and Drug Administration
(FDA)-approved products for the treatment of recurrent VVC.
About SCY-078
SCY-078 is an investigational
antifungal agent that is a semi-synthetic derivative of the natural
product enfumafungin. SCY-078 is 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
IV and oral formulations. SCY-078 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 of anti-fungal 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 SCY-078 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. The
Company's lead product candidate, SCY-078, is a novel IV/oral
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 www.scynexis.com.
Forward Looking Statement
Statements contained in this
press release regarding expected future events or results,
including but not limited to the Company's plans regarding clinical
developments and the timing of data review of clinical trials, 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 SCY-078;
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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