JERSEY CITY, N.J., Oct. 2, 2019 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ: SCYX), a biotechnology company delivering innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced that data, which further
demonstrates the potential of ibrexafungerp as a treatment for
invasive fungal infections, will be presented at IDWeek 2019,
occurring October 2-6, 2019 in
Washington DC, and TIMM-9,
occurring October 11-14, 2019 in
Nice, France. Ibrexafungerp
(formerly SCY-078), the first representative of a novel
triterpenoid antifungal family being developed for oral and
intravenous (IV) usage, is in clinical development for the
treatment of multiple serious fungal infections, including
many that have shown resistance to existing therapies.
"When the Centers for Disease Control and Prevention (CDC) first
alerted the public in 2016 of the threat Candida auris posed
as a dangerous and emerging global pathogen, we immediately began
evaluating the activity of ibrexafungerp against Candida
auris through multiple in vitro, in vivo and
clinical studies," said Dr. David
Angulo, Chief Medical Officer of SCYNEXIS. "To our
knowledge, ibrexafungerp is the first new experimental antifungal
to be tested in patients with Candida auris infections, and
the data so far indicates ibrexafungerp's high activity against
this deadly pathogen. We continue to advance this important new
therapy through our ongoing clinical studies and look forward to
sharing those results in our effort to address these
difficult-to-treat
infections."
Details for the upcoming presentations are as follows:
IDWeek 2019
Title: Activity of Ibrexafungerp (formerly
SCY-078) Against Candida auris: In Vitro, In
Vivo and Clinical Case Studies of Candidemia
Presenter: Stephen Barat, PhD
Date and Time: Thursday, October
3, 2019, 12:15 pm –
1:30 pm ET
Poster Presentation #: 672
Session: Novel Antimicrobials and Approaches Against
Resistant Bugs
Location: Walter E. Washington Convention Center, Washington DC
This poster will highlight a large body of evidence
demonstrating the activity and effectiveness of ibrexafungerp
against Candida auris. In
vitro studies tested ibrexafungerp against >100
clinical isolates of C. auris and evaluated the effects
of ibrexafungerp against C.
auris biofilms. In vivo activity
against C. auris was evaluated using a
disseminated murine model and a cutaneous infection guinea pig
model. In humans, an ongoing open-label trial of oral ibrexafungerp
for treatment of patients with infections caused by C.
auris (the CARES study) is ongoing in the U.S. and
India.
9th Trends in Medical Mycology (TIMM 2019)
Oral Presentation
Title: Ibrexafungerp (formerly
SCY-078)
Presenter: David Angulo, MD
Date and Time: Saturday, October
12, 2019, 5:05 pm –
5:30 pm GMT
Oral Presentation #: 11.3
Session: Symposium 11, The Anti-fungal
Pipeline
Location: Nice-Acropolis Convention Center, Nice,
France
This oral presentation will focus on antifungal agents currently
being developed. Ibrexafungerp is one of three products presented
during this session. The presentation will highlight oral
ibrexafungerp's studies that demonstrate its broad-spectrum of
activity against Candida, Aspergillus and
Pneumocystis, along with its activity against resistant
organisms and development pathway of oral ibrexafungerp for
treatment of hospital-treated fungal infections in patients with
resistant and refractory infections, including Candida
auris.
Poster Presentations
Title: Candida auris is Highly In
Vitro Susceptible to Ibrexafungerp (Formerly SCY-078) in
EUCAST Antifungal Susceptibility Testing
Presenter: Maiken Cavlin Arendrup, MD, PhD
Date and Time: Sunday, October
13, 2019, 11:30 am –
12:30 pm GMT
Poster Presentation #: P414
Location: Nice-Acropolis Convention Center, Nice,
France
Candida auris is a multidrug-resistant yeast rapidly
emerging as a significant cause of nosocomial infections. This
poster will present data on an in vitro study testing the
activity of ibrexafungerp against 122 clinical C. auris
isolates (from India (n=120) and
Oman (n=2)). The in vitro
activity of ibrexafungerp (IBX) against C. auris was uniform
with MICs displaying a Gaussian distribution spanning 0.06-2 mg/L
suggesting an equal efficacy across the 122 isolates. In contrast,
MIC distributions for anidulafungin, micafungin, isavuconazole,
voriconazole, itraconazole and posaconazole were wide (spanning
10-13 dilutions) suggesting differential activity against the
isolates. Ibrexafungerp, a novel oral glucan synthase inhibitor,
shows promising in vitro activity against C. auris,
suggesting it may be a welcomed therapeutic against this emerging
threat with few treatment options.
Title: Successful Treatment of a
Patient with Retroperitoneal Abscess caused by Candida
krusei with the Investigational Agent, Ibrexafungerp (formerly
SCY-078): A Case Report from the FURI study
Presenter: George R. Thompson III, MD
Date and Time: Sunday, October
13, 2019, 11:30 am –
12:30 pm GMT
Poster Presentation #: P402
Location: Nice-Acropolis Convention Center, Nice,
France
This poster presentation will highlight a single case of a
patient with an intra-abdominal fungal infection treated with oral
ibrexafungerp from the FURI study. The case presents a 71-year old
male patient with ischemic stroke, pulmonary edema, and
tracheostomy, treated for a retroperitoneal abscess, a complication
of a perforated duodenal ulcer. Candida krusei was isolated
in peri-duodenal drain cultures and the patient was initiated on
micafungin therapy for 21 days but remained culture positive.
Micafungin therapy was terminated, the patient was enrolled in the
FURI study and ibrexafungerp was initiated for a total of 21 days
of therapy. Clinical improvement was observed during therapy. At
the End-of-Treatment visit, the clinical signs and symptoms of
fungal disease were considered by the investigator to be resolved.
No drug-related adverse events were reported.
Title: Activity of Ibrexafungerp (formerly
SCY-078) Against Candida auris: In Vitro, In
Vivo and Clinical Case Studies of Candidemia
Presenter: David Angulo, MD
Date and Time: Saturday, October
12, 2019, 11:30 am –
12:30 pm GMT
Poster Presentation #: P201
Location: Nice-Acropolis Convention Center, Nice,
France
This poster will highlight the current in vitro, in
vivo and two clinical cases for ibrexafungerp against
Candida auris. In vitro and in vivo studies
demonstrated that ibrexafungerp is active against C. auris,
including multidrug-resistant (MDR) strains. The MIC mode for
ibrexafungerp was 1ug/ml and the MIC50 and
MIC90 were 0.5 and 1 ug/ml, respectively. Many
echinocandin-resistant C. auris isolates have shown
susceptibility to ibrexafungerp. Further, ibrexafungerp has been
shown to reduce biofilm thickness. In animal models of C.
auris infection, treatment with ibrexafungerp resulted in
improved survival and reduced fungal burden in both the murine
model of disseminated infection and the guinea pig model of
cutaneous infection as compared to untreated controls. In humans,
two patients with difficult to treat C. auris candidemias
were enrolled in the CARES study and responded positively to
oral ibrexafungerp with eradication of the infection.
The IDWeek 2019 and TIMM-9 presentations will be available on
the SCYNEXIS website accordingly following each event.
About Ibrexafungerp
Ibrexafungerp [pronounced
eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and
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 oral and intravenous (IV)
formulations. Ibrexafungerp 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 antifungal activity, in
vitro and in vivo, against multidrug-resistant
pathogens, including azole- and echinocandin-resistant strains. The
FDA has granted Qualified Infectious Disease Product (QIDP) and
Fast Track designations for the formulations of ibrexafungerp for
the indications of invasive candidiasis (IC) (including
candidemia), invasive aspergillosis (IA) and VVC (including
prevention of recurrent VVC) and has granted Orphan Drug
Designation for the IC and IA indications. Ibrexafungerp is
formerly known as SCY-078.
About the FURI and CARES Studies
Both studies are
multicenter, open label, non-comparator, single arm studies to
evaluate the safety and efficacy of oral ibrexafungerp in patients
>18 years of age with:
- FURI study: a documented invasive and/or severe mucocutaneous
fungal disease that has been intolerant or refractory (rIFI) to
standard of care (SoC) antifungal treatment.
- CARES study: a documented candidiasis infection, including
candidemia, caused by Candida auris.
In both studies, patients are also considered for enrollment if
they have an eligible fungal disease and, in the judgement of the
investigator, cannot receive approved oral antifungal options
(e.g., susceptibility of the organism or risk for drug-drug
interactions) and continued IV antifungal therapy is not desirable
or feasible due to clinical or logistical
circumstances. Enrolled patients receive an initial loading
dose of 750mg BID (twice a day) of oral ibrexafungerp during the
first two days of treatment and subsequent oral doses of 750mg
QD (once a day) for up to 90 days. Patients are evaluated
several times during treatment, with treatment
efficacy assessed at the end of ibrexafungerp therapy.
Subjects are then followed for another six weeks.
The open-label designs of the FURI and CARES studies allow for
evaluation of the data on an interim basis to further inform
subsequent regulatory steps of the development program. SCYNEXIS
believes that compelling data from the FURI and/or CARES studies
could allow ibrexafungerp to become eligible for the regulatory
Limited Population Pathway for Antibacterial and Antifungal Drugs
(LPAD), potentially resulting in an NDA submission based on
streamlined development. The LPAD was established under the
21st Century Cures Act of 2016, and FDA draft guidance issued in
June 2018 suggests smaller, shorter
or fewer clinical trials may be sufficient to support approval to
treat a serious or life-threatening infection in a limited
population with unmet needs.
More information about the studies can be found at:
- FURI study:
https://clinicaltrials.gov/ct2/show/NCT03059992.
- CARES study:
https://clinicaltrials.gov/ct2/show/NCT03363841.
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, having discovered and developed more than 30
innovative medicines over a broad range of therapeutic areas.
SCYNEXIS's lead product candidate, ibrexafungerp (formerly
known as SCY-078), is a novel IV/oral antifungal agent in Phase 3
clinical and preclinical development for the treatment of multiple
serious and life-threatening invasive fungal infections caused
by Candida, Aspergillus and Pneumocystis species.
For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this
press release regarding expected future events or results 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 ibrexafungerp. 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
Heather
Savelle
Argot Partners
Tel: 212-600-1902
heather@argotpartners.com
Media Relations
George E. MacDougall
MacDougall
Tel: 781-235-3093
george@macbiocom.com
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