SCYNEXIS Completes Two Additional Clinical Studies Further Supporting the Favorable Safety Profile of SCY-078
October 25 2016 - 9:05AM
SCY-078 demonstrates a low potential for certain
drug-drug interactions – a relevant differentiator versus the
azoles, the leading antifungal class – providing an opportunity for
favorable labeling
Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today
announced the completion of two additional Drug-Drug Interaction
(DDI) studies, further demonstrating the favorable safety profile
of SCY-078.
An important milestone in drug development is to understand the
potential impact of how two or more drugs interact with each
other. Patients with invasive fungal infections are typically
immuno-compromised and are commonly treated for long periods of
time with multiple concomitant drugs for their underlying
conditions. The potential for DDIs in these patients results
in labeling restrictions, as is the case for the azole class of
antifungals, which is associated with a high degree of DDIs with
many commonly prescribed drugs.
To date, SCY-078 has been evaluated in multiple in vitro studies
and Phase 1 clinical trials to assess the potential for SCY-078 to
cause DDIs and to interfere with CYP liver enzymes, that are
responsible for the metabolism of most drugs.
- Based on in vitro studies conducted with a broad range of CYP
enzymes, SCY-078 showed minimal interference with most enzymes,
either as a direct inhibitor or inducer, including CYP3A enzymes,
the most common pathway for the metabolism of many drugs. CYP2C8
enzyme was shown to be the enzyme with a higher risk of being
inhibited by SCY-078;
- DDI rosiglitazone clinical study to evaluate CYP2C8 inhibition:
rosiglitazone, an antidiabetic medication, is very sensitive to
inhibition of CYP2C8 and was used as an indicator of the maximum
potential for clinical interaction with oral SCY-078. This study
showed that SCY-078 had no effect on rosiglitazone blood levels
when co-administered (i.e., no meaningful interaction was
observed), indicating a low risk of clinical interactions with
drugs metabolized via CYP enzymes;
- DDI tacrolimus clinical study: tacrolimus is an anti-rejection
drug commonly used for bone marrow and solid organ transplants
patients. Several antifungals, specifically the azoles,
induce an increase of tacrolimus blood levels (typically from two-
to four-fold), resulting in toxicity concerns which frequently
limits the use of the antifungals, and can require major tacrolimus
dose adjustments. In this study, oral SCY-078 had no effect
on the maximum tacrolimus blood levels (no change in Cmax) with
only a minor effect on tacrolimus’ AUC. These results suggest
a low risk of clinical interactions and support the ability of
co-administration of both drugs.
“These results provide further evidence of the favorable safety
profile of SCY-078 and suggest that SCY-078 has low risk for
causing clinically relevant drug interactions,” said Dr. David
Angulo, Chief Medical Officer of SCYNEXIS. “Given the importance of
drug co-administration for these vulnerable patients and the high
risk for DDIs associated with the azoles – the only orally
available antifungal class – we believe these data confirm the
potential for SCY-078 to become a much-needed, potent, safe,
flexible, and easy to administer antifungal alternative for these
life-threatening fungal infections. This is another step towards
completing our registration package and enabling a broad patient
population to be included in our upcoming registration trials.”
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 broad spectrum antifungal activity
of the Polyenes, the well-established safety profile of the
Echinocandins and the flexibility of use (IV and oral formulations)
of the 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 (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 low risk of DDIs with SCY-078are "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: the risk that results in in
vitro studies may not be repeated in clinical trials; and the risk
that unexpected events or results may occur. 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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