SCYNEXIS Presents New Data Supporting Oral SCY-078 for the Clinical Treatment of Vulvovaginal Candidiasis Infections at the 2...
August 14 2017 - 8:00AM
Potent anti-Candida activity shown in vaginal
acidic pH and high penetration into vaginal tissue
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering
innovative anti-infective therapies for difficult-to-treat and
often life-threatening infections, today reported data for SCY-078,
the Company’s lead clinical development candidate, which were
presented at the 2017 Infectious Diseases Society for Obstetrics
and Gynecology (IDSOG) Annual Meeting, August 10-12, 2017 in Park
City, UT. SCY-078 is the first representative of a novel oral and
intravenous (IV) triterpenoid antifungal family in Phase 2 clinical
development for the treatment of several fungal infections,
including vulvovaginal candidiasis (VVC) infections, commonly known
as yeast infections.
“The data presented at IDSOG highlight SCY-078’s high
penetration into vaginal tissue after oral administration and its
potent anti-Candida activity in acidic pH conditions,
characteristic of the vaginal setting. Additionally, the data
showcase the efficacy of SCY-078 vs. fluconazole observed in our
prior Phase 2 study in patients with VVC,” said David Angulo, M.D.,
Chief Medical Officer of SCYNEXIS. “These data affirm the potential
clinical utility of oral SCY-078 and justify its continued
development as a treatment for VVC. We remain encouraged by the
collective data that reveal SCY-078’s potential as an important
treatment option for women suffering from VVC, including those
struggling with recurrent episodes.”
“These data add to the growing body of evidence demonstrating
oral SCY-078’s potential efficacy against Candida in the
vulvovaginal setting,” said Marco Taglietti, M.D., President and
Chief Executive Officer of SCYNEXIS. “With the recent initiation of
our Phase 2 dose-finding study evaluating oral SCY-078 in female
patients with VVC (the DOVE study), we are continuing to maximize
the value of the SCY-078 platform by advancing the oral formulation
of SCY-078. The DOVE study is a critical step towards our goal to
provide a treatment option for VVC patients, particularly those
with recurrent VVC, for which there are currently no approved
therapies.”
SCY-078 Showed Enhanced Potency Against Candida in
Acidic Environments The first poster, “The Effect of pH on
the In Vitro Antifungal Activity of SCY-078,” presented results of
a study showing the in vitro activity of SCY-078 against vaginal
isolates of Candida glabrata and Candida albicans as compared to
other antifungals in neutral and acidic pH levels, representing the
acidic environment of the vagina. SCY-078 exhibited enhanced
potency against the Candida isolates in these acidic pH
environments whereas fluconazole, consistent with
previous reports, showed reduced potency under acidic
conditions.
SCY-078 Showed High Vaginal Tissue
Concentration The second poster, “Vaginal Concentrations
of SCY-078, a Novel Glucan Synthase Inhibitor, Following Oral
Administration in Mice,” presented results of a study on the
vaginal tissue distribution of SCY-078 following oral
administration in mice. In this study, SCY-078 demonstrated vaginal
tissue concentrations that exceed those observed in plasma by
several-fold, confirming SCY-078’s ability to readily distribute
and accumulate in the vagina.
SCY-078 Showed Higher Clinical Cure Rates and a Lower
Recurrence Rate than Standard of Care in Previously Conducted
VVC Phase 2 Study The oral presentation, “A Multicenter,
Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate
the Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in 96
Subjects with Moderate to Severe Vulvovaginal Candidiasis,”
presented the positive results of the Phase 2a proof-of-concept
trial evaluating the safety and efficacy of oral SCY-078 in female
patients with moderate to severe VVC as compared to fluconazole
(the SCY-078-203 study). In this trial, oral SCY-078 demonstrated a
higher clinical cure rate (78.1%) vs. fluconazole (65.6%) at the
test of cure time point (day 24, intent to treat population), as
well as a lower recurrence rate (4%) vs. fluconazole (15%) during
the four-month follow up period. These data highlight oral
SCY-078’s potential as a treatment for VVC and recurrent VVC, most
notably its potential efficacy advantages as compared to
fluconazole.
About SCY-078 SCY-078 is an antifungal agent in
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 with the potential flexibility of
having IV and oral formulations. 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 formulations of SCY-078 for the indications of invasive
candidiasis (including candidemia) and invasive aspergillosis.
About Vulvovaginal Candidiasis (VVC) VVC,
commonly known as a yeast infection, is usually caused
by Candida albicans. 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 as fluconazole, which has a therapeutic cure rate
of 55% per the label. There are no products currently approved for
the treatment of recurrent VVC.
About SCYNEXISSCYNEXIS, 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 Statement Statements 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 on the IV formulation of SCY-078 on a timely
basis, if at all, 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: 781-591-3443
cduong@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
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