JERSEY CITY, N.J., Oct. 23, 2018 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ:SCYX), a biotechnology company delivering innovative
therapies for difficult-to-treat and often life-threatening
infections, today announced the successful completion of an
End-of-Phase 2 Meeting with the U.S. Food and Drug Administration
(FDA) for its lead product candidate, ibrexafungerp (formerly
SCY-078), for patients with vulvovaginal candidiasis (VVC). The FDA
has agreed with the Company's proposed overall design of the Phase
3 registration program to support approval of oral ibrexafungerp
for the treatment of VVC and prevention of recurrent VVC. SCYNEXIS
expects to initiate the program in the fourth quarter of 2018.
Ibrexafungerp, the first representative of a novel oral and
intravenous (IV) triterpenoid antifungal family, is in clinical
development for the treatment of multiple serious fungal
infections, including VVC, invasive candidiasis (IC), invasive
aspergillosis (IA) and refractory invasive fungal infections. If
approved, Ibrexafungerp would be the only oral alternative to
azoles for the treatment of VVC and prevention of recurrent
VVC.
"We are very pleased with the outcome of our End-of-Phase 2
meeting with the FDA, which provides a clear and straightforward
regulatory path towards approval in both acute and recurrent VVC,"
said Marco Taglietti, M.D.,
President and Chief Executive Officer of SCYNEXIS. "With only one
oral treatment option currently available for women with VVC, and
no approved products for recurrent VVC, we believe oral
ibrexafungerp can address the unmet needs in this highly prevalent
infection, with the potential of achieving U.S. peak sales of
$400-$600
million. Based on the positive feedback from the FDA, we
reaffirm our guidance to initiate our registration program by
year-end. With a cash runway into 2020, we are well-positioned to
successfully execute our Phase 3 program, with a plan to file a New
Drug Application (NDA) for the treatment of VVC in 2020."
The VVC registration program will be comprised of three global,
multi-center, randomized, double-blind, placebo-controlled trials
designed to demonstrate superiority of oral ibrexafungerp vs.
placebo:
- Treatment of VVC: Two Phase 3 clinical trials will
evaluate the safety and efficacy of the one-day, oral 600mg dose of
ibrexafungerp (two doses of 300mg 12 hours apart), compared to
placebo, in approximately 700 patients total (approximately 350
patients per trial). Patients with a diagnosis of VVC will be
randomized to ibrexafungerp or placebo in a 2:1 ratio. Similar to
the design of the Phase 2 DOVE study, the primary endpoint of each
trial will be clinical cure rate (complete resolution of all signs
and symptoms [S&S]) at the Test-of-Cure visit (Day 10).
Secondary endpoints include mycological eradication, need for
antifungal rescue therapy and change in S&S scores at Day 10
and at the follow-up visit (Day 25).
- Prevention of Recurrent VVC: One Phase 3 clinical trial
will evaluate the safety and efficacy of the oral 600mg dose of
ibrexafungerp (two doses of 300mg 12 hours apart) given
once-a-month for six months, compared to placebo, in approximately
350 patients. Patients with a diagnosis of VVC and a history of at
least three episodes of VVC in the past 12 months (including the
current episode) will be randomized to ibrexafungerp or placebo in
a 1:1 ratio after successful treatment of the active infection. The
primary endpoint of the trial will be the percentage of patients
without recurrence of VVC through the Test-of-Cure visit (Week 24).
Secondary endpoints include time to first recurrence, mycological
eradication and percentage of patients without recurrence of VVC
through the treatment and subsequent follow-up period.
Pending successful completion of these trials, the Company
anticipates filing an initial NDA for oral ibrexafungerp for the
treatment of VVC in 2020 and a supplemental NDA for the prevention
of recurrent VVC in 2021.
"Our Phase 2b DOVE study showed
oral ibrexafungerp to have high clinical cure and mycological
eradication rates, sustained clinical benefit compared to
fluconazole and a favorable tolerability profile," said
David Angulo, M.D., Chief Medical
Officer of SCYNEXIS. "Based on these positive clinical data, we are
confident in our ability to conduct a successful registration
program that will demonstrate statistical superiority of
ibrexafungerp over the control. In addition, the
differentiated attributes of ibrexafungerp versus fluconazole for
this indication, most notably its fungicidal activity against
Candida spp. including azole-resistant strains, enhanced
antifungal activity in the acidic conditions of the vaginal
environment and the fact that it has shown no adverse impact on
embryo/fetal development in pre-clinical studies, will provide
significant benefits to women not well-served by current
treatments."
In May 2018, SCYNEXIS announced
the receipt of Qualified Infectious Disease Product (QIDP) and Fast
Track designations from the FDA for the treatment of VVC and
prevention of recurrent VVC. QIDP designation provides eligibility
for priority review and an additional five years of market
exclusivity in the U.S. for ibrexafungerp. The FDA's Fast
Track Drug Development Program is a process designed to expedite
the development and review of drugs to treat serious conditions and
fill unmet medical needs.
About Vulvovaginal Candidiasis (VVC)
VVC, commonly
known as a "vaginal yeast infection," is the second most common
cause of vaginitis and is usually caused by Candida
albicans. 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 8% of the 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 over-the-counter (OTC)
topical azole antifungals (clotrimazole, miconazole, and others)
and the prescription oral azole antifungal, fluconazole.
Fluconazole, the only orally-administered antifungal currently
approved for acute VVC in the U.S., reported a 55% therapeutic cure
rate in its label, 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
treatment of recurrent VVC.
About Ibrexafungerp (formerly SCY-078)
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 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 QIDP and Fast
Track designations for the formulations of ibrexafungerp for the
indications of IC (including candidemia), IA and VVC, and has
granted Orphan Drug Designation for the IC and IA indications.
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, discovering and developing more than 30
innovative medicines over a broad range of therapeutic areas. The
Company's lead product candidate, ibrexafungerp (formerly
known as SCY-078), is a novel IV/oral antifungal agent in Phase 2
clinical and preclinical development for the treatment of multiple
serious and life-threatening invasive fungal infections caused by
Candida and Aspergillus 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, statements regarding: expectations for the timing of
initiation of clinical trials, anticipated timing of the filing of
an NDA for acute VVC in 2020 and recurrent VVC in 2021: 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:
Media Relations
George E.
MacDougall
MacDougall Biomedical Communications
Tel: 781-235-3093
george@macbiocom.com
Investor Relations
Natalie
Wildenradt
Argot Partners
Tel: 212-600-1902
natalie@argotpartners.com
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