SCYNEXIS, Inc. Receives Orphan Drug Designation for SCY-078 for the Treatment of Invasive Aspergillus Infections
August 24 2016 - 9:05AM
Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today
announced that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation to the Company’s novel triterpenoid
broad-spectrum antifungal agent, SCY-078, for the treatment
of invasive Aspergillus infections.
The orphan drug designation of SCY-078 provides
seven years of market exclusivity in the U.S. following FDA
approval of an NDA for the orphan designated indication. This is
the second U.S. orphan designation received for SCY-078. Earlier
this year, the Company announced that SCY-078 received orphan drug
designation for the treatment of invasive Candida infections,
including candidemia. The Company was previously granted Qualified
Infectious Disease Product (QIDP) designation for both the IV and
oral formulations of SCY-078, which provides an additional five
years of exclusivity. Together, these designations provide SCYNEXIS
with a potential 12 years of market exclusivity in the U.S. upon
FDA approval.
"The FDA's decision to grant SCY-078 orphan drug
designation for invasive Aspergillus infections is another
important milestone in the development of our lead compound
recognizing the broad antifungal spectrum of this novel antifungal
agent. We believe SCY-078 has the potential to be a unique
treatment option for patients with acute and chronic fungal
infections caused by Aspergillus," said Marco Taglietti, M.D.,
President and Chief Executive Officer of SCYNEXIS. "SCY-078 has
clinically-relevant attributes such as high tissue penetration and
distribution, reduced risk for drug-drug interactions, activity
against azole-resistant pathogens and versatile administration with
both oral and IV formulations. If approved, SCY-078 would currently
be the only alternative to azoles to treat invasive Aspergillus
infections (including azole-resistant strains), with the
flexibility of both oral and IV formulations."
In the U.S., under the Orphan Drug Act, the
FDA's Office of Orphan Products Development grants orphan drug
designation to products intended to treat rare diseases or
conditions, which are defined by the FDA as those affecting fewer
than 200,000 people in the U.S.. In addition to the potential U.S.
market exclusivity in the specified indication, if SCYNEXIS
complies with certain FDA requirements, the designation provides
several benefits and incentives, including tax credits related to
qualified clinical trial expenses, eligibility for orphan drug
grants, and an exemption from FDA application fees.
About Invasive Aspergillus
Infections
Invasive aspergillosis is a serious fungal
infection caused by Aspergillus species that usually affects people
who have weakened immune systems, such as people who have had an
organ transplant or a stem cell transplant. Invasive aspergillosis
most commonly affects the lungs, but it can also spread to other
parts of the body. There are approximately 46,000 cases of invasive
aspergillosis reported in the U.S. annually, with a mortality rate
as high as 50%. Current standard of treatment is 8 to 12 weeks of
azoles usually started as IV treatment for one to two weeks
followed by oral step-down treatment for several weeks.
About SCY-078
SCY-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 a recently
reported Phase 2 proof-of-concept study in a mucocutaneous Candida
spp. infection (acute vulvovaginal candidiasis) 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 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.
Forward Looking Statement
Statements contained in this press release
regarding the expected benefits of SCY-078, the expected timing of
results from clinical trials and expected benefits of orphan drug
designation 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; and the
risk that unexpected events may occur that may delay the reporting
of results from clinical trials. 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
Heather Savelle
MacDougall Biomedical Communications
Tel: 781.235.3060
hsavelle@macbiocom.com
Investor Relations
Susan Kim
Argot Partners
Tel: 212.203.4433
susan@argotpartners.com
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