JERSEY CITY, N.J., Jan. 4, 2018 /PRNewswire/ -- SCYNEXIS, Inc.
(NASDAQ: SCYX), a biotechnology company delivering innovative
anti-infective therapies for difficult-to-treat and often
life-threatening infections, today provided a corporate update,
including recent pipeline developments and anticipated milestones
in 2018, for its lead antifungal candidate, SCY-078. SCY-078 is the
first representative of a novel oral and intravenous (IV)
triterpenoid antifungal family in clinical and pre-clinical
development for the treatment of several serious fungal infections,
including invasive candidiasis, invasive aspergillosis, refractory
invasive fungal infections and vulvovaginal candidiasis (VVC).
"In 2017, we made significant progress in advancing the clinical
development of SCY-078 in indications addressable and approvable
with an orally-administered antifungal therapy," said Marco Taglietti, M.D., President and Chief
Executive Officer of SCYNEXIS. "In addition, we advanced the IV
program of SCY-078 to address the clinical hold placed by the U.S.
Food and Drug Administration (FDA) following thrombotic events
observed in a Phase 1 study. We plan to restart clinical
trials with IV SCY-078 in the third quarter of 2018, using a
liposomal IV formulation that has shown an improved tolerability
profile in pre-clinical assessments compared with the
cyclodextrin-based IV formulation used in the earlier study."
Dr. Taglietti continued: "We are excited about our strategic
plans for 2018, when we envision SCY-078 advancing in multiple
Phase 2 and Phase 3 trials to maximize the broad potential clinical
utility of SCY-078 in addressing unmet medical needs in VVC,
invasive candidiasis, invasive aspergillosis and refractory
invasive fungal infections."
Path Forward Established for IV Program of SCY-078, with
Clinical Trials to Initiate in the Third Quarter of 2018 with an
Improved IV Formulation
As previously disclosed in March
2017, the FDA required SCYNEXIS to hold the initiation of
any new clinical studies of the IV formulation of SCY-078 following
the review of three mild-to-moderate inflammation-related
thrombotic events in healthy volunteers receiving the IV
formulation at the highest dose level in a Phase 1 study.
That study used a cyclodextrin-based IV formulation.
- Broad Pre-clinical Program Executed to Address the Clinical
Hold. Based on subsequent interactions with the FDA, SCYNEXIS
completed a broad range of pre-clinical activities designed to
identify the underlying cause of the thrombotic events and to
evaluate the optimal administration regimen for the
cyclodextrin-based IV formulation of SCY-078. In parallel, SCYNEXIS
continued its pursuit of alternative IV formulations.
-
- No Intrinsic Pro-Coagulant Effect of the SCY-078
Compound. Several pre-clinical studies showed that SCY-078 does
not affect blood coagulation by itself, providing supporting
evidence that the thrombotic events associated with the
administration of the cyclodextrin-based IV formulation were
triggered by vascular endothelium inflammation at the site of
infusion.
- Accelerated Development of a Liposomal IV Formulation of
SCY-078. During 2017, SCYNEXIS accelerated the development of a
new formulation based on liposomal technology. This technology has
been successfully used to improve systemic tolerability of other
commercially available IV formulations.
- Favorable Profile of the Liposomal IV Formulation of
SCY-078. SCYNEXIS compared the cyclodextrin-based IV
formulation head-to-head against the liposomal IV formulation of
SCY-078 in pre-clinical evaluations, and the liposomal formulation
showed a superior profile for infusion-related tolerability and
vascular inflammation.
- Pre-clinical Activities Ongoing to Enable Planned Human
Studies of the Liposomal IV Formulation of SCY-078. Based on
these initial pre-clinical studies, SCYNEXIS believes that the
liposomal IV formulation may offer significant clinical benefits
over the cyclodextrin-based IV formulation and, therefore, decided
to focus its efforts on the advancement of the liposomal IV
formulation of SCY-078. This decision was discussed with the FDA
and a path forward was established. Additional pre-clinical studies
are ongoing, and SCYNEXIS intends to initiate a Phase 1 study in
healthy volunteers in the third quarter of 2018, pending FDA's
review.
- Phase 2b Study in Invasive
Candidiasis. Upon successful completion of the Phase 1 study in
healthy volunteers, SCYNEXIS plans to initiate a Phase 2b study of SCY-078 in invasive candidiasis with
the liposomal IV formulation in the fourth quarter of 2018.
Clinical Development of Oral Formulation of SCY-078 Continues
to Progress as Planned in Multiple Indications Approvable with an
Oral Agent
SCYNEXIS is pursuing several programs where the oral formulation of
SCY-078 has the potential to be a suitable treatment for
indications with significant unmet medical needs and considerable
commercial potential.
- VVC – Most Advanced Stage of Clinical Development,
Targeting Both Acute and Recurrent Infections.
-
- Rapid Recruitment in the Phase 2 Dose-finding DOVE
Study. In August 2017, SCYNEXIS
initiated dosing in the Phase 2 study, designed to evaluate the
safety and efficacy of the oral formulation of SCY-078 vs. oral
fluconazole, the standard of care, for the treatment of VVC. Robust
enrollment in the trial has been maintained, and SCYNEXIS continues
to expect top-line results in mid-2018. In a previously conducted,
proof-of-concept, Phase 2a study in VVC patients, SCY-078 showed
high clinical cure and low recurrence rates.
- Initiation of Phase 3 Program Planned for the Fourth Quarter
of 2018. SCYNEXIS anticipates that the dose regimen selected
from the DOVE study will be subsequently evaluated in Phase 3
studies following an End-of-Phase 2 meeting with the FDA. SCYNEXIS
expects to initiate the Phase 3 clinical program in the fourth
quarter of 2018.
- Refractory Invasive Fungal Infections – Potential for
Streamlined Development Pathway.
-
- Enrollment Ongoing in the FURI Study for the Treatment of
Patients with a Wide Range of Candida spp. Infections with
Limited or No Treatment Options. Sixteen sites in the U.S and
Europe are now active in this
open-label study, and enrollment is progressing as planned.
- CARES Study Opened for Enrollment for the Treatment of
Patients with Candida auris Infections. Systemic
infections caused by C. auris, a pathogen that is often
multidrug-resistant, are associated with high
mortality. The CARES study is designed to provide rapid access to
oral SCY-078 for patients with this life-threatening and
difficult-to-treat infection. This emergency protocol allows for
expeditious site initiation upon request from investigators.
- Both FURI and CARES Studies Designed as Pivotal Trials to
Support a Potential Approval. The open-label design of these
studies allows for evaluation of the data on an interim basis to
further inform subsequent regulatory steps of the development
program.
- Invasive Aspergillosis – SCY-078 in Combination with
Standard of Care May Represent a Significant Opportunity to Improve
Outcomes for this High-Mortality Infection.
-
- Favorable Profile of SCY-078. SCYNEXIS believes that
SCY-078's broad activity against Aspergillus spp., including
azole-resistant strains, along with its minimal drug-drug
interactions, high tissue penetration into the lungs and oral
formulation allowing for long-term administration, make it an ideal
candidate for use as combination therapy to provide improved
outcomes vs. standard of care.
- Promising In Vitro and In Vivo Data with
Combination Use of SCY-078 and Standard of Care vs.
Aspergillus spp. In recent pre-clinical studies, the
combination of SCY-078 with other antifungal agents resulted in
significantly better outcomes when compared to treatment with
single agents.
- Plan to initiate Phase 2 Study in the Third Quarter of
2018. This initial study in patients with invasive
aspergillosis is planned as a randomized, double-blind trial with
the objective of assessing the safety and efficacy of oral SCY-078
in combination with azole therapy, the standard of care for this
indication. SCYNEXIS is finalizing the study design and expects to
start this clinical study in the third quarter of 2018.
2018 Key Upcoming Milestones
- Complete enrollment and announce top-line study results of the
Phase 2b study of oral SCY-078 as a
treatment for VVC in mid-2018.
- Initiate the Phase 1 clinical trial to evaluate the safety and
tolerability of the liposomal IV formulation of SCY-078 in healthy
volunteers in the third quarter of 2018.
- Initiate a Phase 2 study of oral SCY-078 in combination with
current standard of care as a treatment for invasive aspergillosis
in the third quarter of 2018.
- Upon successful completion of the Phase 1 study, initiate a
Phase 2b clinical trial designed to
evaluate IV/oral SCY-078 for the treatment of invasive candidiasis.
SCYNEXIS expects to initiate this study in the fourth quarter of
2018.
- Initiate the Phase 3 program for VVC in the fourth quarter of
2018.
- Continue to advance enrollment in both the FURI and CARES
studies, both in the U.S. and globally, with preliminary data
review planned for the fourth quarter of 2018.
Conference Call Details
SCYNEXIS will host a conference call today at 5:00pm Eastern Time to provide a general
corporate and SCY-078 pipeline update, as well as to present its
plans for 2018. The call can be accessed by dialing 844-309-3707 or
661-378-9467 prior to the start of the call and referencing
conference ID: 2897769. The conference call will also be webcast
live over the Internet and can be accessed on the "Investors"
section of the SCYNEXIS website, www.scynexis.com.
About SCY-078
SCY-078 is an investigational antifungal agent
that is a semi-synthetic derivative of the natural
product enfumafungin. SCY-078 is 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 IV and oral formulations. SCY-078
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 of antifungal
activity, in vitro and in
vivo, against multi-drug resistant pathogens, including
azole- and echinocandin-resistant strains.
The FDA 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 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 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 a novel IV/oral antifungal agent in
Phase 2 clinical and pre-clinical development for the treatment of
several 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 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 regarding the IV
formulation of SCY-078 on a timely basis, if at all, and obtain
FDA's 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:
Investor Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
Media Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
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SOURCE SCYNEXIS, Inc.