Galectin Therapeutics Reports no Drug-Drug Interaction Between GR-MD-02 and Midazolam
May 14 2015 - 8:00AM
Galectin Therapeutics Inc. (Nasdaq:GALT), the
leading developer of therapeutics that target galectin proteins to
treat fibrosis and cancer, reports that in an open-label Phase 1
study with 8 mg/kg dose of GR-MD-02 and 2 mg/kg dose of midazolam
there was no drug-drug interaction and no serious adverse events or
drug-related adverse events were observed. This study was required
by the U.S. Food and Drug Administration (FDA) and the primary
objective was to determine if single or multiple intravenous (IV)
doses of GR-MD-02 affect the pharmacokinetics (PK) of midazolam.
The secondary objective was to assess the safety and tolerability
of GR-MD-02 when administered concomitantly with midazolam.
The lack of a drug interaction in this study will permit
Galectin to expand the number of patients eligible for its Phase 2
clinical trial. In addition, should GR-MD-02 be approved for
marketing, the success of this study supports a broader patient
population for the drug label.
"The success of this study is important to the advancement of
GR-MD-02 as a treatment for non-alcoholic steatohepatitis (NASH)
with fibrosis and/or cirrhosis because midazolam is widely used in
clinical practice for mild, conscious sedation. Importantly,
midazolam provides a good model for many other commonly used drugs
that are metabolized by the CYP3A4 enzyme system, to which patients
with liver disease might be exposed to for a variety of clinical
indications," said Peter G. Traber, M.D., president, chief
executive officer and chief medical officer of Galectin
Therapeutics. "We are very pleased to find no pharmacokinetic
issues with GR-MD-02 and midazolam following single and multiple
doses of both drugs. The rigorous conduct of this study was a
requirement by the FDA and overcomes one more important hurdle in
our efforts to bring a drug to address the needs of a growing
number of patients who develop NASH, and subsequently progress to
liver fibrosis and cirrhosis. "
The open-label Phase 1 study in normal healthy volunteer
subjects tested a single dose of IV midazolam in the absence of
GR-MD-02, following a single IV dose of GR-MD-02 and following
three weekly IV doses of GR-MD-02. The four dosing periods were
spaced one week apart, with midazolam PK determined in dosing
periods one, two and four. A total of 17 subjects completed the
study and met the primary endpoint of midazolam clearance when
administered alone, compared with when administered with single and
multiple doses of GR-MD-02. Drug to drug interaction studies are an
integral part of understanding how a drug will affect patients who
are also on other drugs. With completion of this study, the company
does not anticipate further drug-drug interaction studies will be
required in the development of GR-MD-02.
Dr. Traber added, "We are preparing to begin patient screening
for our Phase 2 program in the coming weeks, which consists of a
study in patients with NASH cirrhosis and a study in NASH patients
with advanced fibrosis, but not cirrhosis. It should be noted as we
embark on the next steps of our development strategy that Galectin
has significantly invested in the chemical and pharmaceutical
development of our compound, has implemented analytical methods to
meet FDA requirements and is continually generating the necessary
data to adequately characterize our drug compound. When a new
chemical entity is chosen and defined as a potential drug
candidate, the drug must be fully characterized. This drug
characterization is necessary to understand the behavior of the
drug, in solid state (drug substance) as well as in solution (drug
product). Our working relationships with academic institutions and
commercial analytical organizations with expertise in carbohydrate
chemistry and analytical characterization of complex carbohydrate
molecules helps to assure that our products are adequately
characterized using the latest available technologies."
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based
therapies for the treatment of fibrotic liver disease and cancer
based on the Company's unique understanding of galectin proteins,
which are key mediators of biologic function. Galectin seeks to
leverage extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. The Company is pursuing a
development pathway to clinical enhancement and commercialization
for its lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to future events or future financial
performance, and use words such as "may," "estimate," "could,"
"expect" and others. They are based on management's current
expectations and are subject to factors and uncertainties that
could cause actual results to differ materially from those
described in the statements. These statements include those
regarding the hope that Galectin's development program for GR-MD-02
will lead to the first therapy for the treatment of fatty liver
disease with cirrhosis. Factors that could cause actual performance
to differ materially from those discussed in the forward-looking
statements include, among others, that Galectin may not be
successful in developing effective treatments and/or obtaining the
requisite approvals for the use of GR-MD-02 or any of its other
drugs in development. The Company's current clinical trial and any
future clinical studies may not produce positive results in a
timely fashion, if at all, and could prove time consuming and
costly. Plans regarding development, approval and marketing of any
of Galectin's drugs are subject to change at any time based on the
changing needs of the Company as determined by management and
regulatory agencies. Carbohydrates are a relatively new drug class,
and regulatory requirements are evolving; we cannot assure that
will be able to meet such requirements in a timely and cost
effective manner in the manufacturing and characterization of our
products. Regardless of the results of any of its development
programs, Galectin may be unsuccessful in developing partnerships
with other companies or raising additional capital that would allow
it to further develop and/or fund any studies or trials. Galectin
has incurred operating losses since inception, and its ability to
successfully develop and market drugs may be impacted by its
ability to manage costs and finance continuing operations. For a
discussion of additional factors impacting Galectin's business, see
the Company's Annual Report on Form 10-K for the year ended
December 31, 2014, and subsequent filings with the SEC. You should
not place undue reliance on forward-looking statements. Although
subsequent events may cause its views to change, management
disclaims any obligation to update forward-looking statements.
Galectin Therapeutics and its associated logo is a registered
trademark of Galectin Therapeutics Inc.
CONTACT: Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
LHA
Kim Golodetz
(212) 838-3777
kgolodetz@lhai.com
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