Galectin Therapeutics Announces Results From 12-Week Extension of Phase 2a Psoriasis Clinical Trial
August 25 2016 - 8:00AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
announces interim results from an exploratory, open-label, Phase 2a
clinical trial with GR-MD-02 in patients with moderate-to-severe
plaque psoriasis.
In May, the company announced significant improvement in PASI
(Psoriasis Area and Severity Index) scores at the 12-week mark for
all four patients in the study (7 infusions of 8 mg/kg every other
week). These results prompted an extension of treatment for an
additional 12 weeks at the same dose and dosing interval (13 total
infusions). Four patients have now completed 24 weeks of therapy
with GR-MD-02, and a fifth patient has completed 12 weeks. Despite
the extension of treatment, the original four patients have
experienced minimal additional improvement in their psoriasis
beyond that first reported in May.
“We are pleased to report that there is clinically meaningful
activity of GR-MD-02 for the treatment of moderate to severe
psoriasis,” said Peter G. Traber, M.D., Galectin’s president, chief
executive officer and chief medical officer. “Moreover, this
activity in a human disease, strongly associated with NASH and
increased galectin-3 expression, suggests that GR-MD-02 may also
have activity in NASH, which remains the company’s primary
target.
“While the improvement among the patients is significant, we
have to consider the extent of improvement in the context of
biological agents for psoriasis currently on the market or in
development. The primary endpoint for these existing agents is a
75% improvement in PASI, and none of our patients reached that
level of improvement at the dose level and duration administered in
the study. There are potential advantages which GR-MD-02 might have
over biological agents, such as safety and cost, and the current
safety profile of GR-MD-02 does support the possibility of studying
higher doses or a more frequent dosing regimen for psoriasis.
However, without much more study, these potential advantages remain
untested.”
Galectin Therapeutics conducted this small psoriasis study
because of an unexpected positive effect on the psoriasis of a NASH
patient in the Company's Phase 1 trial in liver disease. Given the
Company’s focus on the phase 2 program in NASH with advanced
fibrosis and cirrhosis, additional studies to develop GR-MD-02 as a
psoriasis treatment will not occur at this time. The Company may
later conduct additional studies in psoriasis either directly or
through a partner who may wish to take this forward.
“The results of the psoriasis trial confirm GR-MD-02 is active
in a human disease,” concluded Traber. “The Company continues to
pursue the application of GR-MD-02 for the treatment of NASH with
liver fibrosis and cirrhosis which has always been the primary
focus of our business.”
Results of the 24-week psoriasis trial are shown in the table
below.
Patient |
Baseline PASI Score |
After 7 Doses |
After 13 Doses |
PASI Score |
Percent improvement from baseline |
PASI Score |
Percent improvement from baseline |
1 |
13.6 |
8.1 |
|
40 |
% |
7.4 |
|
46 |
% |
2 |
14.6 |
7.9 |
|
46 |
% |
6.0 |
|
59 |
% |
3 |
12.3 |
10.6 |
|
14 |
% |
9.0 |
|
27 |
% |
4 |
12.8 |
4.3 |
|
66 |
% |
5.1 |
|
60 |
% |
5 |
19.1 |
12.7 |
|
34 |
% |
NA |
NA |
NA: Data not currently available
About PsoriasisPsoriasis, which manifests most
often as plaque psoriasis, is a chronic, relapsing, inflammatory
skin disorder. Although plaque psoriasis is rarely life
threatening, it often is intractable to treatment. According to the
International Federation of Psoriasis Associations, about 3% of the
world’s population has some form of psoriasis. In the U.S. there
are about 150,000 new cases every year, and psoriasis affects about
2% of the U.S. population, according to the Cleveland Clinic.
About GR-MD-02GR-MD-02 is a complex
carbohydrate drug that targets galectin-3, a critical protein in
the pathogenesis of fatty liver disease and fibrosis. Galectin-3
plays a major role in diseases that involve scarring of organs
including fibrotic disorders of the liver, lung, kidney, heart and
vascular system. The drug binds to galectin proteins and disrupts
their function. Preclinical data in animals have shown that
GR-MD-02 has robust treatment effects in reversing liver fibrosis
and cirrhosis.
About Galectin TherapeuticsGalectin
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 StatementsThis 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 NASH, or fatty liver disease, with cirrhosis and/or an
additional therapy for the treatment of moderate to severe
psoriasis and that positive results in treating psoriasis may have
implications for the treatment of 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. 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 complete its current trials or
further develop and/or fund further 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, 2015, 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.
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com.
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