Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today
announced the complete results of its two recently completed Phase
2 studies as well as the closing of a $15 million term loan with
Solar Capital Ltd. (Nasdaq:SLRC).
In the first study, treatment with oral SCY-078 in patients with
vulvovaginal candidiasis (VVC), resulted in significantly better
clinical cure rates and fewer recurrences of VVC at the four-month
follow-up when compared to the standard of care (oral fluconazole).
In the second study, which evaluated oral SCY-078 as a step down
therapy in patients with invasive candidiasis, oral SCY-078
achieved the target exposure for efficacy and was
well-tolerated.
"We are delighted with these positive results that support the
concept that a fungicidal product with high tissue penetration like
SCY-078 could yield superior clinical outcomes," said David Angulo,
M.D., Chief Medical Officer of SCYNEXIS. “We identified a
well-tolerated oral dose that achieves our target exposure in
invasive candidiasis patients, and further confirmed the antifungal
activity of oral SCY-078 in two independent human models of Candida
infections. These results support our planned development of
SCY-078 as the first drug in a novel antifungal class for the
treatment of a broad range of fungal infections with growing unmet
medical needs.”
Phase 2 Proof-of-Concept Study of Oral SCY-078 in
Patients with VVCThe first study evaluated the effect of
two dose regimens of SCY-078 in patients with moderate to severe
VVC as a proof-of-concept study to support the development of
SCY-078 in invasive candidiasis and other Candida infections.
Clinical cure rate, defined as a resolution of signs and symptoms
of infection without further antifungal treatment, is now the
recommended primary endpoint per the latest FDA guidelines for
VVC. As previously reported, clinical cure rate was higher
for patients receiving oral SCY-078 compared to oral fluconazole at
the test of cure visit (Day 24). Additionally, follow-up data
now available showed a high clinical cure rate at the four-month
visit (end of observation period) of 88% in patients who received
SCY-078 compared to 65% in patients who received fluconazole
(p=0.04). Moreover, during the four-month observation period,
patients who received SCY-078 had a lower recurrence rate (4%)
versus fluconazole (15%).
Phase 2 Study of Oral SCY-078 in Patients with Invasive
CandidiasisThe second study evaluated the pharmacokinetics
(PK), safety, and tolerability of SCY-078 as an oral step-down
treatment in patients initially treated with intravenous (IV)
echinocandin therapy for invasive Candida infections.
Twenty-two patients were randomized to receive study drug or
standard of care (one of the patients randomized to standard of
care could not receive oral fluconazole due to a Candida glabrata
with decreased fluconazole-susceptibility and received micafungin
for the entire duration of antifungal therapy). As previously
reported, the study met its primary objective by confirming the
once daily oral dose of SCY-078 750mg as a dose that is both
overall safe and tolerated and achieves the target exposure in
these patients. During the study period, there were no reports of
mycological failures in the SCY-078 750mg group (n=7) versus two
infection-related failures (one fungemia and one abdominal sepsis)
in the fluconazole group (n=7). No relapses were observed in
these two groups during the six-week follow-up period.
As previously reported, SCY-078 was overall safe and tolerated
in both studies. There were no discontinuations due to adverse
events (AEs) and no related serious AEs. Consistent with previous
findings, the most common AEs were mild to moderate
gastrointestinal (GI) events such as diarrhea nausea, vomiting,
abdominal pain or discomfort. In patients with invasive
candidiasis, the number of GI events were comparable in both the
SCY-078 and fluconazole treatment arms.
"We achieved our stated goals and further de-risked the
development of our lead product candidate, SCY-078," said Marco
Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS.
“With these positive Phase 2 data in hand, we believe SCY-078 is
now the most advanced novel agent in a new antifungal class that
can address the growing issue of resistance. We are also pleased to
announce the infusion of additional funds from Solar Capital,
providing us with the financial strength and flexibility to
accelerate and expand the development of SCY-078 and to leverage
our internal antifungal platform.”
Additional Capital RaisedSCYNEXIS closed a $15
million term loan with Solar Capital, fully funded at close.
This transaction complements the company’s recent equity raise, and
results in minimal dilution to shareholders. Please refer to
the Form 8-K filing with the Securities and Exchange Commission for
additional information about the facility.
"Solar Capital is pleased to start a financing partnership with
SCYNEXIS that should enable the company to expand its pipeline of
indications for SCY-078, as well as accelerate its other
development programs," said Anthony Storino, head of life science
lending at Solar Capital. “We believe SCYNEXIS offers a unique
value proposition in an area with significant unmet medical needs,
and we are excited to contribute to the company’s growth and future
successes.”
As of September 30, 2016, SCYNEXIS’ preliminary estimate of its
cash, cash equivalents and marketable securities totaled $58.4
million, including the $15 million from the loan facility.
Armentum Partners acted as financial advisor to SCYNEXIS on the
loan facility.
About the Studies
Phase 2 Proof-of-Concept Study of Oral SCY-078 in
Patients with Vulvovaginal Candidiasis (VVC)Multicenter,
randomized, active controlled, evaluator-blinded study
(clinicaltrials.gov identifier: NCT02679456) of oral SCY-078
compared to oral fluconazole in adult female patients with acute
vulvovaginal candidiasis (VVC). A total of 96 patients with an
acute moderate to severe, symptomatic episode of VVC were
randomized in a 1:1:1 ratio to receive either three daily doses or
five daily doses of oral SCY-078 750mg QD with a 1,250mg loading
dose or oral fluconazole, at the labeled approved dose regimen of
150mg single dose. This was a pilot investigation and not powered
to demonstrate a statistical significant difference in the
parameters tested (p values for the comparisons mentioned were
>0.05 unless otherwise indicated). Efficacy was evaluated based
on the proportion of patients achieving clinical cure, mycological
eradication and therapeutic cure (combination of both clinical cure
and mycological eradication) at day 24 (+/-3) after initiation of
treatment. The 3-day and the 5-day SCY-078 regimens performed
similarly, allowing a pooled analysis. Intent-to-treat (ITT)
population is defined as all subjects randomized (n=96 subjects).
Per-Protocol (PP) population is defined as subjects with culture
confirmed Candida infection at baseline (n=70 subjects).
Subjects in the PP population were followed for four months.
Recurrence was defined as a symptomatic VVC episode requiring
additional antifungal therapy, per investigators’ decision.
Phase 2 Study of Oral SCY-078 in Patients with Invasive
CandidiasisMulticenter, multinational, randomized,
open-label study (clinicaltrials.gov identifier: NCT02244606)
following three to ten days of IV echinocandin therapy. A total of
27 patients with invasive candidiasis were enrolled and 22 were
randomized to receive either SCY-078 500mg QD with a 1,000mg
loading dose (7 patients), SCY-078 750mg QD with a 1,250mg loading
dose (7 patients) or standard of care (7 patients receiving
fluconazole 400mg QD with a 800mg loading dose and 1 patient
receiving micafungin IV 100mg QD due to a Candida glabrata with
decreased fluconazole-susceptibility for up to 28 days). Efficacy
was assessed based on achievement of favorable global response
defined as the resolution of signs and symptoms attributable to the
Candida infection and mycological eradication without the use of
any other antifungal agent. Patients were followed for six
weeks after the end of treatment.
About SCY-078SCY-078 is an oral and IV glucan
synthase inhibitor in Phase 2 clinical development for the
treatment for fungal infections caused
by Candida and Aspergillus species. SCY-078 is
a semi-synthetic triterpene derivative of the natural product
enfumafungin—a structurally distinct class of glucan synthase
inhibitor. SCY-078 combines the well-established activity of glucan
synthase inhibitors (similar to echinocandins) with the flexibility
of having intravenous (IV) and oral formulations (similar to
azoles). 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. Positive
results from two recently reported Phase 2 studies provided
evidence of the antifungal activity of orally administered SCY-078
in patients with Candida infections. The U.S. Food and
Drug Administration (FDA) granted Fast Track, Qualified Infectious
Disease Product (QIDP) and orphan drug designations (ODD) for the
oral and IV formulations of SCY-078 for the indications of invasive
Candida infections (including candidemia) and
invasive Aspergillus infections.
About Invasive CandidiasisInvasive candidiasis
is a serious, often life-threatening infection caused by Candida
species that typically affects a highly vulnerable population such
as immunocompromised patients or patients under intensive care in
hospital settings. We estimate that the U.S. annual incidence
is approximately 98,000 cases with high mortality rates (i.e.,
20-40%) despite currently available antifungal agents. Furthermore,
the limited number of antifungal drug classes, consisting of
azoles, echinocandins and polyenes, and their widespread use, has
led to increased numbers of candida infections with drug-resistant
strains. The Centers for Disease Control and Prevention (CDC) has
listed fluconazole-resistant Candida as a serious public health
threat requiring prompt and sustained action.
About Vulvovaginal CandidiasisVVC, commonly
known as a "yeast infection," is usually caused by Candida
albicans and 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 fluconazole, which has a therapeutic cure rate of
55% as reported in the label. There are no products currently
approved for the treatment recurrent VVC.
About SCYNEXIS, Inc.SCYNEXIS is a
pharmaceutical company committed to the development and
commercialization of novel anti-infectives to address significant
unmet therapeutic needs. We are developing our lead product
candidate, SCY-078, as an oral and IV drug for the treatment of
serious and life-threatening invasive fungal infections. For more
information, visit www.scynexis.com.
About Solar CapitalSolar Capital Partners, the
investment advisor to Solar Capital Ltd., Solar Senior Capital Ltd.
and other affiliated funds, primarily invests in leveraged, middle
market companies in the form of senior secured loans, unitranche
loans, mezzanine loans, and equity securities. As of June 30, 2016,
Solar Capital Partners has invested approximately $5.6 billion in
more than 250 different portfolio companies since it was founded in
2006 and has completed transactions with more than 145 different
financial sponsors and venture capital firms.
Solar Capital’s life science lending segment provides financing
solutions for bio-pharma, medical device, healthcare IT and
healthcare services companies, both venture-backed private and
public, and from pre-revenue clinical to early commercial
stage.
Forward Looking StatementStatements contained
in this press release regarding the expected benefits from the loan
agreement, including SCYNEXIS’s belief that it provides the company
with the financial strength and flexibility to accelerate and
expand the ongoing development of SCY-078 and to leverage its
internal antifungal platform, and the expected benefits of SCY-078,
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 due to a number of factors, including: regulatory
risks; the risk that results in prior trials may not be repeated in
subsequent trials; the risk that unexpected events may occur that
may delay the reporting of results from clinical trials; and the
risk that unexpected costs will be incurred in the clinical trials
or otherwise. These risks 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 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
Blair Atkinson
MacDougall Biomedical Communications
Tel: 781.235.3060
batkinson@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212.203.4433
susan@argotpartners.com
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