SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today announced eight poster
presentations at ASM Microbe 2017, June 1 through 5 in New Orleans,
LA. All presentations will feature the company’s lead candidate,
SCY-078, the first representative of a novel intravenous (IV) and
oral triterpenoid antifungal family in Phase 2 clinical development
for the treatment of several fungal infections, including invasive
candidiasis, invasive apergillosis and vulvovaginal candidiasis
infections.
“Following an active ECCMID 2017, the large set of data to be
presented further confirms the versatility of SCY-078 across
treatment settings and against a wide array of Candida and
Aspergillus fungal species,” said Marco Taglietti, M.D., President
and Chief Executive Officer of SCYNEXIS. “SCY-078’s compatibility
in combination with other frequently used drugs and high tissue
penetration into organ systems where infections occur are
significant differentiators for this novel anti-infective. These
presentations further support the potential broad applicability of
SCY-078 and its ability to be a next-generation agent to fight
these infections, including multi-drug-resistant pathogens such as
Candida auris.”
Further details on these presentations will be available on the
SCYNEXIS website following the event. All abstracts are available
on the ASM Microbe 2017 Online Program Planner.
The details of the presentations are as follows:
Title: Pharmacokinetics and Pharmacodynamics in
Patients from a Phase 2, Multicenter, Open-Label, Randomized,
Comparative Study of Oral SCY-078 vs. Standard-of-Care Following
Initial Intravenous Echinocandin Therapy in the Treatment of
Invasive Candidiasis (Including Candidemia) in Hospitalized
Non-Neutropenic AdultsDate and Time: Friday, June
2 from 12:45 – 2:45 p.m. CDTLocation: Exhibit Hall
DPoster Presentation #:
193Session: Antimicrobial Pharmacokinetics:
Antifungal PK/PD Studies
Title: In Vitro Interaction between SCY-078,
Echinocandins and Azoles against Susceptible and Resistant Candida
spp. Determined by the Checkerboard MethodDate and
Time: Friday, June 2 from 12:45 – 2:45 p.m.
CDTLocation: Exhibit Hall DPoster
Presentation #: 248Session: Mycology:
Clinical and Laboratory Studies of Antifungal Drug Resistance
Title: CYP-Mediated Drug Interaction Profile of
SCY-078, a Novel Triterpene Glucan Synthase Inhibitor
(GSI)Date and Time: Saturday, June 3 from 12:15 –
2:15 p.m. CDTLocation: Exhibit Hall
DPoster Presentation #:
173Session: Antimicrobial Stewardship and Quality
of Care: Antibiotic Safety
Title: Lack of an Effect of SCY-078, a Novel
Antifungal Agent on QTc Interval in Healthy SubjectsDate
and Time: Saturday, June 3 from 12:15 – 2:15 p.m.
CDTLocation: Exhibit Hall DPoster
Presentation #: 172Session: Antimicrobial
Stewardship and Quality of Care: Antibiotic Safety
Title: Pharmacokinetics of SCY-078 Following
Intravenous Administration in Rabbits: Implications for Treatment
of Experimental Invasive Pulmonary AspergillosisDate and
Time: Saturday, June 3 from 12:15 – 2:15 p.m.
CDTLocation: Exhibit Hall DPoster
Presentation #: 231Session: Mycology: New
Antifungal Agents I
Title: Assessment of the In Vitro Antifungal
Activity of SCY-078 against a Panel of Susceptible and Resistant,
Clinical Candida Isolates from EuropeDate and
Time: Sunday, June 4 from 12:15 – 2:15 p.m.
CDTLocation: Exhibit Hall DPoster
Presentation #: 308Session: Mycology: New
Antifungal Agents II
Title: SCY-078, a Novel Intravenous and Oral
Antifungal Agent, Demonstrates Extensive Tissue Distribution in
Rats Following Single Intravenous Infusions and Oral Doses of
[14C]SCY-078Date and Time: Sunday, June 4 from
12:15 - 2:15 p.m. CDTPoster Presentation #:
309Session: Mycology: New Antifungal Agents II
Title: Susceptibility Testing of SCY‐078
against Candida Isolates Obtained from a Clinical Study of Oral
SCY‐078 vs. Oral Fluconazole in Subjects with Moderate to Severe
Vulvovaginal Candidiasis Demonstrates No Resistance
DevelopmentDate and Time: Sunday, June 4 from
12:15 – 2:15 p.m. CDTLocation: Exhibit Hall
DPoster Presentation #:
307Session: Mycology: New Antifungal Agents II
About SCY-078SCY-078 is an oral and IV
antifungal agent in Phase 2 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 (similar to echinocandins)
with the potential flexibility of having IV and oral formulations
(similar to azoles). 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 oral and IV
formulations of SCY-078 for the indications of invasive candidiasis
(including candidemia) and invasive aspergillosis.
About Invasive Candidiasis InfectionsInvasive
candidiasis is a serious, often life-threatening infection caused
by Candida species that typically affects a highly vulnerable
population such as immunocompromised patients or patients under
intensive care in hospital settings. The U.S. annual
incidence is estimated to be approximately 100,000 cases with high
mortality rates (i.e., 20-40%) despite currently available
antifungal agents. Furthermore, the limited number of antifungal
drug classes, consisting of azoles, echinocandins and polyenes, and
their widespread use, has led to increased numbers of candida
infections with drug-resistant strains. The CDC has listed
fluconazole-resistant Candida as a serious public health threat
requiring prompt and sustained action.
About Invasive Aspergillus InfectionsInvasive
aspergillosis is a serious fungal infection caused by Aspergillus
species that usually affects people who have weakened immune
systems, such as people who have had an organ transplant or a stem
cell transplant. Invasive aspergillosis most commonly affects the
lungs, but it can also spread to other parts of the body. There are
approximately 50,000 cases of invasive aspergillosis reported in
the U.S. annually, with a mortality rate as high as 50%. Current
standard of treatment is eight to 12 weeks of azoles usually
started as IV treatment for one to two weeks followed by oral
step-down treatment for several weeks.
About Vulvovaginal Candidiasis
InfectionsVulvovaginal candidiasis (VVC), commonly known
as a "yeast infection," is usually caused by Candida albicans and
typical symptoms include pruritus, vaginal soreness, irritation and
abnormal vaginal discharge. An estimated 75% of women will have at
least one episode of VVC during their lifetime and 40%-45% will
experience two or more episodes. As many as 8% of these patients
suffer from recurrent VVC, defined as experiencing at least four
episodes a year. Current treatments for VVC include topical
antifungals and the use of prescription oral antifungals such
fluconazole, which has a therapeutic cure rate of 55% as reported
in the label. There are no products currently approved for the
treatment recurrent VVC.
About SCYNEXIS, Inc.SCYNEXIS, 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 intravenous and oral 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 StatementStatements 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.
CONTACTS:
Media Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-235-3060
cduong@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
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