Presentations support SCY-078's potential as a
novel treatment for Candida infections including
multidrug-resistant strains
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today announced results showing
evidence of activity of the company's lead product candidate
SCY-078 against fungal infections in multiple settings and
indications. These results were described in a total of eight oral
and poster presentations at the 27th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID), held April 22
through 25, 2017 in Vienna, Austria.
The first oral presentation (#OS0846) described new data from a
multicenter Phase 2 trial that examined oral SCY-078 compared with
standard-of-care (oral fluconazole or intravenous micafungin)
following initial intravenous (IV) echinocandin therapy for the
treatment of invasive candidiasis. SCY-078 demonstrated safety
among all treatment groups and achieved a global response rate
similar to standard-of-care. Additionally, an estimated dose to
achieve target exposure was identified. The findings support the
use of oral SCY-078 in the treatment of invasive candidiasis
following initial IV echinocandin therapy.
“We’re seeing a rising incidence of patients becoming resistant
to today’s current therapies treating invasive candidiasis, which
poses a global health threat,” said Peter G. Pappas, M.D., lead
investigator on the study and Professor at the University of
Alabama at Birmingham. “The discovery and development of
potentially novel therapies, like SCY-078, are vital to the
management of these invasive and life-threatening infections.”
The second oral presentation (#EP0698) described the antifungal
activity of SCY-078 against the emerging drug-resistant fungal
infection Candida auris. In this preclinical study, SCY-078
impacted the growth morphology and biofilm formulation of these
invasive and life-threatening fungal species. Results showed potent
activity of SCY-078 against all strains at concentrations
indicative of a potential clinically-relevant effect.
“Candida auris is an emerging, multidrug-resistant fungal
species now infecting patients globally, with a mortality rate of
approximately 60%,” said Mahmoud Ghannoum, Ph.D., Professor at the
Center for Medical Mycology in the Department of Dermatology at
Case Western Reserve School of Medicine. “Given that certain fungal
strains that have been isolated from patients have proven to be
resistant to all commercially available antifungal drugs, the need
for effective new therapies has become a dire global health
need.”
The remaining presentations – all delivered via poster
presentations – detailed the results of six separate studies, which
assessed the safety, efficacy, and pharmokonetics of SCY-078 across
both Aspergillus and Candida strains. All studies supported the
significant antifungal activity and positive safety profile found
to date. Conclusions from the poster presentations included:
• In vitro synergies of SCY-078 in combination with
other antifungals against Aspergillus
- The combination of SCY-078 with three antifungals (amphotericin
B, voriconazole and isavuconazole) demonstrated synergy in the
majority of strains tested
• Safety and efficacy of SCY-078 in two Phase 1
drug-drug interaction studies
- Co-administration with tacrolimus had no effect on maximum
blood levels and only mild effect on AUC, indicating a low risk for
a clinically-meaningful interaction
- SCY-078 also demonstrated compatibility with rosiglitazone,
suggesting low risk for interaction with drugs metabolized via CYP
enzymes
• Additional posters confirming SCY-078’s broad spectrum
of activity in clinical and pre-clinical settings
- Evidence of potent antifungal effect in a proof-of-concept
study for vulvovaginal candidiasis infections
- High in vitro activity against invasive Candida isolates in
biofilms comparable to micafungin
- High antifungal activity found against 178 Candida isolates
from Europe through CLSI and EUCAST procedures
“The wide range of clinical and non-clinical results from the
SCY-078 development program at ECCMID provide further evidence of
its strong anti-fungal effect and the significant impact it could
have in treating patients, both as a stand-alone treatment and in
combination with currently marketed drugs,” said Marco Taglietti,
M.D., President and Chief Executive Officer of SCYNEXIS. “These
results support our commitment to building not only next-generation
therapeutics but a platform of much-needed, potent, safe, flexible
and easy-to-administer anti-infective alternatives.”
In addition to data presentations, SCYNEXIS provided an overview
of its pipeline and recent advances at ECCMID. This overview, along
with all presentations and posters, are available at
www.SCYNEXIS.com.
Conference Call Details
SCYNEXIS will hold a conference call today at 4:05 p.m. ET to
discuss the SCY-078 data presented at ECCMID. SCYNEXIS management
will be joined by global thought leaders Mahmoud Ghannoum, Ph.D.,
Professor and Director of the Center for Medical Mycology at Case
Western Reserve University and University Hospitals Cleveland
Medical Center, and Oliver Cornely, M.D., Professor of Internal
Medicine and Medical Director, Clinical Trials Center Cologne at
the University of Cologne in Germany. The call can be accessed:
U.S. Dial-In Number: 844-309-3707 International Dial-In Number:
661-378-9467 Conference ID: 12180429
The slide and audio webcast can be accessed by visiting the
Investors section of the Company's website
at http://ir.scynexis.com. A replay of the webcast will be
available shortly after the conclusion of the call and will be
archived on the Company's website for 30 days.
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 Candida auris InfectionsCandida auris, a
fungal strain first reported in 2009, has been linked to invasive
fungal infections in nine countries, including the U.S., and has
caused at least two hospital outbreaks involving more than 30
patients each. The CDC estimates that infections with C. auris are
associated with a mortality rate of approximately 60% and that some
strains of this species of Candida have proven to be resistant to
all three major classes of antifungal drugs, making treatment
difficult. This type of broad resistance to approved antifungal
agents has not been observed in other species of Candida. Types of
infections caused by C. auris include bloodstream, wound and ear
infections. The fungal strain has also been isolated from
respiratory and urine specimens, although it is unclear if it
causes infections in the lung or bladder. The CDC is actively
tracking C. auris infections globally and has already issued an
alert to all healthcare facilities classifying this new pathogen as
a serious global health threat.
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. 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 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
Scynexis (NASDAQ:SCYX)
Historical Stock Chart
From Apr 2024 to May 2024
Scynexis (NASDAQ:SCYX)
Historical Stock Chart
From May 2023 to May 2024