JERSEY CITY, N.J., Sept. 18, 2019 /PRNewswire/ -- SCYNEXIS,
Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced completion of the
last-patient/last-visit in its Phase 3 VANISH 303 study, and that
it expects to release top-line data earlier than previously
reported. Ibrexafungerp (formerly SCY-078) is the first
representative of a novel family of antifungal compounds referred
to as triterpenoids. SCYNEXIS is developing ibrexafungerp for the
treatment of both serious outpatient fungal infections as well as
hospital-based, life-threatening fungal infections.
"I am proud to report that our VVC clinical studies are
progressing ahead of schedule, showing the execution strength of
our team. The last patient has completed her last visit in our
first Phase 3 study, VANISH 303, and we now expect top-line data by
the end of this year," said Marco
Taglietti, M.D., President and Chief Executive Officer of
SCYNEXIS. "Additionally, enrollment is also advancing ahead of
expectations in our second Phase 3 study, VANISH 306, with data now
anticipated in early second quarter of 2020."
Dr. Taglietti continued, "The rapid enrollment observed in our
VVC studies reaffirms our belief that a large number of patients
and their treating physicians are not satisfied with existing
therapies and are looking for alternatives. It provides validation
of our VVC commercial expectations for ibrexafungerp, as a
non-azole, fungicidal, oral agent. We remain on-track for a New
Drug Application (NDA) submission in the second half of 2020."
Ibrexafungerp Update:
Significant progress made in the Phase 3 VANISH program
evaluating the safety and efficacy of oral ibrexafungerp (300mg BID
for one day) for the treatment of VVC
- The VANISH program is comprised of two Phase 3, randomized,
double-blind, placebo-controlled, multi-center studies:
-
- The VANISH 303 study was conducted in U.S. centers and enrolled
376 patients. The last patient has now completed her final visit,
ahead of schedule. Top-line data from the study is now expected by
year-end 2019. More information about this study can be found at:
https://clinicaltrials.gov/ct2/show/NCT03734991.
- The VANISH 306 study is expected to enroll approximately 360
patients from sites in the U.S. and Europe; the enrollment rate is also exceeding
expectations, and the Company now anticipates top-line data in
early second quarter of 2020. More information about this study can
be found at: https://clinicaltrials.gov/ct2/show/NCT03987620.
- All NDA preparatory activities remain on track to support a
planned NDA submission in the second half of 2020.
About Vulvovaginal Candidiasis (VVC)
VVC, commonly known as a "vaginal yeast infection," is the
second most common cause of vaginitis. Although these infections
are frequently caused by Candida albicans,
fluconazole-resistant Candida strains, such as Candida
glabrata, have been reported to become increasingly more
common. VVC can be associated with substantial morbidity, including
significant genital discomfort, reduced sexual pleasure,
psychological distress and loss of productivity. Typical VVC
symptoms include pruritus, vaginal soreness, irritation,
excoriation of vaginal mucosa and abnormal vaginal discharge. An
estimated 70-75% of women worldwide will have at least one episode
of VVC in their lifetime, and 40-50% of them will experience two or
more episodes. Approximately 6-8% of women with VVC suffer from
recurrent disease, defined as experiencing at least three episodes
within a 12-month period.
Current treatments for acute VVC include several topical azole
antifungals (clotrimazole, miconazole, and others) and fluconazole,
the only orally-administered antifungal currently approved for
acute VVC in the U.S. Fluconazole reported a 55% therapeutic cure
rate in its label, which now also includes warnings of potential
for fetal harm, illustrating the need for new oral alternatives.
The needs of women with moderate-to-severe VVC, recurrent VVC, VVC
caused by fluconazole-resistant Candida spp. or VVC during
child-bearing age are not fully addressed by oral fluconazole or
topical products. In addition, there are no oral alternatives for
VVC patients who do not respond to or tolerate fluconazole, and
there are no FDA-approved products for the prevention of recurrent
VVC.
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 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; the expected costs of studies and
when they might begin or be concluded; and SCYNEXIS's reliance on
third parties to conduct SCYNEXIS's clinical studies. 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.