JERSEY CITY, N.J., Feb. 1, 2018 /PRNewswire/ -- SCYNEXIS,
Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often
life-threatening infections, today announced new preclinical data supporting the potential of SCY-078, the Company's lead product
candidate, for the treatment of Aspergillus infections at the 8th Advances Against Aspergillosis (AAA),
February 1-3, 2018, in Lisbon, Portugal. SCY-078, the first
representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment
of several serious fungal infections, including invasive candidiasis, invasive aspergillosis, refractory invasive fungal
infections and vulvovaginal candidiasis.
The oral presentation, titled "Combination Therapy with SCY-078 and Isavuconazole for Treatment of Experimental Invasive
Pulmonary Aspergillosis," delivered by the infectious diseases translational research team from Weill Cornell Medicine of
Cornell University, describes the results of a study designed to evaluate the in vivo efficacy
of SCY-078 in combination with isavuconazole (ISA), an azole used for the treatment of invasive pulmonary aspergillosis
(IPA).
- Date and Time: Thursday, February 1 from 14.55-15.10 WET
- Session: Therapy for the Next Decade
"The data presented at AAA show synergistic activity of SCY-078 at two different doses in combination with ISA against
Aspergillus in a relevant in vivo model, suggesting the potential for improved patient outcomes for this
high-mortality infection with significant unmet medical need," said David Angulo, M.D., Chief
Medical Officer of SCYNEXIS. "Specifically, the combination resulted in significantly prolonged survival, decreased pulmonary
injury, and lower serum galactomannan antigenemia (GMI). SCY-078's profile, encompassing broad activity against
Aspergillus spp., including azole-resistant strains, favorable safety profile with minimal drug-drug interactions, high
pulmonary tissue penetration and oral bioavailability, renders it an optimal candidate for combination therapy for the treatment
of invasive aspergillosis. We remain committed to maximizing the therapeutic versatility of SCY-078, and we plan to evaluate oral
SCY-078 in combination with a mold-active azole for this indication in a Phase 2 trial on track to initiate in the third quarter
of this year."
In the in vivo study, conducted using an established model of experimental IPA, neutropenic rabbits were divided into
four experimental study groups where treatment involved either a daily IV administration of a low (2.5mg/kg/day) or high dose
(7.5mg/kg/day) of SCY-078; a single dose (40mg/kg/day) of ISA; a combination of either the low or high dose of SCY-078 with ISA;
or no treatment as part of the untreated control group. The following results were observed:
- Prolonged survival in rabbits treated with both combination groups compared to all single-therapy arms (p<0.05);
- Decreased infarct scores in rabbits treated with both combination groups compared to all single-therapy arms (p<0.01);
and
- Lower serum GMI in rabbits treated with combination regimen of SCY7.5+ISA40 compared to the single therapy arms of SCY7.5,
ISA40, and untreated controls (p<0.05).
These results further confirm in vitro data that demonstrated the synergistic and additive activity of SCY-078 in
combination with ISA against Aspergillus spp.
The presentation is available on the Scientific Publications page of the SCYNEXIS website.
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 anti-fungal
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 preclinical 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, to 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.
C ONTACT:
I n ve s t o r Relations
Susan Kim
Argot Partners
Tel: 212-203-4433
susan@argotpartners.com
Med i a Relations
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
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