JERSEY CITY, N.J., May 6, 2019 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ: SCYX), a biotechnology company delivering innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced data demonstrating the potential of
ibrexafungerp as an agent to address VVC. The data, which were
presented at the 2019 American College of Obstetrics and Gynecology
Annual Clinical and Scientific Meeting (ACOG), further support the
company's plan to submit a New Drug Application (NDA) for VVC in
the second half of 2020.
"The data presented at ACOG 2019 adds to a growing body of
evidence demonstrating the favorable safety profile and the
antifungal activity of ibrexafungerp against difficult-to-treat and
often drug-resistant Candida infections," said Stephen A. Barat, PhD, Vice President of
Pre-Clinical Research and Early Development at SCYNEXIS. "We are
particularly pleased with the positive results observed in our
complete reproductive and developmental toxicology package, which
allow us to move closer to our planned NDA submission for VVC in
the second half of 2020. Reproductive and developmental
studies (fertility and early embryonic, embryo-fetal, peri- and
post-natal) provide evidence that ibrexafungerp does not cause
fetal or reproductive harm. These findings are extremely meaningful
for the VVC patient population, often of child-bearing age, and can
differentiate oral ibrexafungerp against fluconazole, which has a
warning for potential risks of spontaneous abortion and congenital
abnormalities in its prescribing information."
Details of the presentations are as follows:
Poster Title: Ibrexafungerp, a Novel Oral
Antifungal, Demonstrates No Reproductive or Developmental Harm in
Preclinical Models
A full developmental and reproductive toxicity package for
ibrexafungerp was recently concluded, as required for approval and
labeling of prescription medications. These preclinical studies
included investigation of the effects of ibrexafungerp on a)
fertility and libido of adult male and female animals during
treatment; b) conception, implantation and development of embryos;
c) development of fetuses, parturition, survival and lactation; d)
the development of offspring from birth through sexual maturation;
and e) the ability of those offspring to mate and conceive a
second-generation post exposure. The studies indicate that
ibrexafungerp does not result in reproductive harm to adult animals
nor does it result in developmental harm to offspring.
Presentation Title: In Vitro Activity of
Ibrexafungerp (SCY-078) Against Candida spp. (including
Fluconazole-resistant Isolates)
In vitro MIC data for ibrexafungerp against multiple
Candida spp. were compiled from seven independent studies.
The combined studies included 242 isolates with fluconazole
resistance (FLU-R) and 532 wild-type (WT) isolates of C.
albicans, C. glabrata, C. tropicalis and C.
parapsilosis. The MIC50 values for ibrexafungerp
against the WT isolates ranged from 0.008 to 0.5 ug/mL. Similar
results were obtained against FLU-R strains, for which
ibrexafungerp MIC50 values ranged from 0.06 to 0.5
ug/mL. Overall, ibrexafungerp was active (MIC within two dilutions
of WT) against 240/242 (99%) of the FLU-R isolates tested in these
studies.
Poster Title: A Phase 2b, Dose-Finding Study Evaluating Oral
Ibrexafungerp vs Fluconazole in Vulvovaginal Candidiasis (DOVE)
In a randomized, double-blind, double-dummy Phase 2b study, subjects received either one of five
oral ibrexafungerp dose regimens (750mg-QD 1 day, 300mg-BID 1 day,
450mg-BID 1 day, 150mg-BID for 3 days, and 300-BID for 3 days) or
an active comparator dose of oral fluconazole (FLU) (150mg single
dose). Subjects were then evaluated for clinical cure and
mycological eradication at Day-10 and Day-25. Subjects receiving
the ibrexafungerp dose of 300mg BID for one day (600mg-dose),
showed the best combination of clinical response and tolerability.
At Day-10, clinical cure, defined as complete resolution of all
signs and symptoms, was observed in 14 of 27 (52%) subjects in the
ibrexafungerp 600mg-dose arm and 14 of 24 (58%) subjects in
the FLU arm. At Day-25, the rate of clinical cure in the
ibrexafungerp 600mg-dose arm reached 70% compared to 50% in
the FLU arm. At Day-10 and Day-25, the mycological eradication
rates were 63% and 48% for the ibrexafungerp 600mg-dose arm
and 63% and 38% for the FLU arm. The most common AEs were mild
nausea and diarrhea.
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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SOURCE SCYNEXIS, Inc.