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.
C ONTACT:
I n ve s t o r Relations
Natalie Wildenradt
Argot Partners
Tel: 212-600-1902
natalie@argotpartners.com
Med i a Relations
George E. MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com
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SOURCE SCYNEXIS, Inc.