Oral presentation of Phase 2 study discusses oral
SCY-078 in patients with invasive candidiasis
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
life-threatening infections, today announced eight data
presentations at the 27th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID), April 22 to 25,
2017, in Vienna, Austria.
All presentations will feature data related to the development
of the company’s lead product 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 serious and
life-threatening invasive fungal infections.
“SCY-078 is proving to be broad spectrum, active against
resistant strains, versatile as both IV and oral treatments with
high tissue distribution, fungicidal activity and a favorable
safety profile,” said Marco Taglietti, M.D., president and CEO
of SCYNEXIS. “Our significant presence at ECCMID emphasizes our
strong ties to the scientific community and our commitment to
delivering novel products to treat these life-threatening fungal
infections, including new and multi-drug-resistant pathogens like
C. auris that are becoming a major global threat. The
SCYNEXIS’ scientific team, in collaboration with renowned academic
centers, has generated valuable data that reinforce the unique
attributes of SCY-078, a promising candidate offering the potential
to positively impact the way severe fungal infections are
treated.”
Along with the oral data presentation detailed below, SCYNEXIS
will provide an overview of its pipeline and recent advances in the
ECCMID 2017 Pipeline Corner at 1:00 p.m. CEDT on Sunday, April
23.
All abstracts are available on the ECCMID website at
www.eccmidlive.org.
Oral Presentations
Title: A prospective, phase 2, multicentre,
open-label, randomized, comparative study to estimate the safety,
tolerability, pharmacokinetics, and efficacy of oral SCY-078 vs
standard-of-care following initial intravenous echinocandin therapy
in the treatment of invasive candidiasis (including candidaemia) in
hospitalized non-neutropenic adults (mycoses study group
010)Date and time: Tuesday, April 25 from 9:00 –
9:10 a.m. CEDTLocation: Hall FPresentation
number: OS0846Session: Challenges in
antifungal treatment
Title: The emerging Candida auris: antifungal
activity of SCY-078, a novel glucan synthesis inhibitor, on growth
morphology and biofilm formation Date and time:
Monday, April 24 from 1:42 – 1:47 p.m.
CEDTLocation: ePoster Arena 5Presentation
number: EP0698Session: Candida
infections: from changing epidemiology to changing treatment
Posters
Title: Evaluation of the antifungal activity of
SCY-078 in combination with other antifungals against Aspergillus
strainsDate and time: Saturday, April 22 from 8:45
- 3:30 p.m. CEDTLocation: ePoster Viewing
AreaPoster number: EV0123Session:
Fungal infection & disease
Title: A multicentre, randomized,
evaluator-blinded, active-controlled study to evaluate the safety
and efficacy of oral SCY-078 in subjects with moderate to severe
vulvovaginal candidiasisDate and time: Tuesday,
April 25 from 12:30 - 1:30 p.m. CEDTLocation:
Paper Poster AreaPoster number:
P1742Session: Antifungal drugs and treatment
II
Title: Effect of SCY-078 on the
pharmacokinetics of CYP2C8 substrate (rosiglitazone), results from
a phase 1 clinical trialDate and time: Tuesday,
April 25 from 12:30 - 1:30 p.m. CEDTLocation:
Paper Poster AreaPoster number:
P1713Session: Antifungal drugs and treatment I
Title: Effect of SCY-078 on the
pharmacokinetics of tacrolimus, results of a phase 1 drug-drug
Interaction clinical trialDate and time: Tuesday,
April 25 from 12:30 - 1:30 p.m. CEDTLocation:
Paper Poster AreaPoster number:
P1738Session info: Antifungal drugs and treatment
II
Title: Activity of SCY-078 against Candida spp.
obtained by EUCAST and CLSI proceduresDate and
time: Tuesday, April 25 from 12:30 - 1:30 p.m.
CEDTLocation: Paper Poster AreaPoster
number: P1761Session: Antifungal
resistance
Title: The novel oral glucan synthase inhibitor
SCY-078 shows in-vitro activity against Candida spp.
biofilmsDate and time: Tuesday, April 25 from
12:30 - 1:30 p.m. CEDTLocation: Paper Poster
AreaPoster number: P1762Session:
Antifungal resistance
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
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. We estimate that the
U.S. annual incidence is 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 Centers for Disease
Control and Prevention (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., a
biotechnology company committed to delivering innovative
anti-infective therapies that will transform treatment paradigms
and positively impact the lives of patients suffering from
difficult-to-treat and life-threatening infections. The SCYNESIS
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 regarding the expected benefits and efficacy
of SCY-078 are "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Because these
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by these
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 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.
CONTACT:
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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